On September 4, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported new data from a post hoc subgroup analysis from the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) versus comparator chemotherapies (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies (Press release, Gilead Sciences, SEP 4, 2022, View Source;Metastatic-Breast-Cancer-Patients-Demonstrates-Progression-Free-Survival-Benefit-of-Trodelvy-Regardless-of-Their-HER2-Status/default.aspx [SID1234618971]). The analysis examined progression-free survival (PFS) in the intention-to-treat population by HER2-immunohistochemistry (IHC) status, and the results demonstrated that Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups.

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Summary of results:

Detailed findings will be presented at a mini-oral session (Abstract #1362) during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in the Évry Auditorium, Paris Expo Porte de Versailles, on September 10.

"These data demonstrate Trodelvy’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients in the TROPiCS-02 trial," said Professor Peter Schmid, Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre. "Once patients have developed resistance to endocrine-based therapies, their prognosis is extremely poor. The results highlight the potential for Trodelvy as a treatment option for people living with pre-treated HR+/HER2- metastatic breast cancer, regardless of their HER2-negative status."

"These results show Trodelvy improved progression-free survival regardless of HER2 status in this pre-treated patient population and reinforce the strength of clinical activity in a population where need is highest," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "Trodelvy is already transforming the standard of care in second-line metastatic triple-negative breast cancer, and we’re excited about its potential in other breast cancers where there is significant need for new treatment options."

In the study, HER2 negativity was defined per American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the College of American Pathologists (CAP) criteria as immunohistochemistry (IHC) score of 0, IHC 1+ or IHC 2+ with a negative in-situ hybridization (ISH) test.

Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication. Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) based on data from TROPiCS-02; these data will also be shared with health authorities outside the U.S.

Sacituzumab govitecan is currently included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)i. This includes a Category 1 recommendation for use in adult patients with second-line metastatic triple-negative breast cancer (defined as those who received at least two prior therapies, with at least one line for metastatic disease). It also has a Category 2A preferred recommendation for investigational use in HR+/HER2- advanced breast cancer after prior treatment including endocrine therapy, a CDK4/6 inhibitor and at least two lines of chemotherapy.

Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.

About HR+/HER2- Breast Cancer

Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. In this setting, it is common to receive multiple lines of chemotherapy regimens over the course of treatment, and the prognosis remains poor.

About the TROPiCS-02 Study

The TROPiCS-02 study is a global, multicenter, open-label, Phase 3 study, randomized 1:1 to evaluate Trodelvy versus physicians’ choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy for metastatic disease. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) for participants treated with Trodelvy compared to those treated with chemotherapy. Secondary endpoints include overall survival, overall response rate, clinical benefit rate and duration of response, as well as assessment of safety and tolerability and quality of life measures. More information about TROPiCS-02 is available at View Source

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

U.S. Indications for Trodelvy

In the United States, Trodelvy is indicated for the treatment of:

Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold Trodelvy until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with Trodelvy and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPHY study (IMMU-132-06), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

On September 4, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 from September 9 to 13 in Paris (Press release, Regeneron, SEP 4, 2022, View Source [SID1234618969]). Presentations will include first-in-class efficacy and safety data from Phase 1/2 trials of two investigational bispecific antibodies – ubamatamab (REGN4018; MUC16xCD3) in advanced ovarian cancer and REGN5093 (METxMET) in advanced MET-altered non-small cell lung cancer (NSCLC) – along with presentations of investigational Libtayo (cemiplimab) regimens in four advanced solid tumors, including a combination with investigational fianlimab (LAG-3 inhibitor).

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"Our ESMO (Free ESMO Whitepaper) presentations showcase the broad promise of Regeneron’s oncology pipeline of checkpoint inhibitors and bispecifics – many of which are also being studied in combinations for potentially synergistic treatments," said David Weinreich, M.D., Executive Vice President, Global Clinical Development at Regeneron. "To date, we’ve advanced 14 oncology medicines into the clinic, shown preliminary therapeutic benefits in solid tumors and clinically meaningful results for hematological malignancies with several investigational bispecific antibodies, and received global regulatory approvals for our PD-1 inhibitor Libtayo in multiple cancers. The achievements and progress we’ve made with our oncology pipeline provide a strong foundation as we propel our potentially transformative oncology research forward."

Regeneron currently has three classes of investigational bispecifics in ongoing Phase 1/2 trials. Data for two of these classes will be presented at ESMO (Free ESMO Whitepaper), including a mini-oral on the CD3-targeting bispecific ubamatamab (designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local tumor-specific T-cell activation) and a poster presentation on the tumor-targeting bispecific REGN5093 (designed to target two different parts of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation). Preliminary clinical data on a third class of investigational bispecific, REGN5678, a CD28-targeted costimulatory bispecific, in advanced castration-resistant prostate cancer were shared in August.

New and updated investigational data for Libtayo as monotherapy and as a potential backbone of several combination treatments will also be presented at ESMO (Free ESMO Whitepaper). In skin cancers, this includes a mini-oral sharing updated expansion cohort results for Libtayo in combination with Regeneron’s LAG-3 inhibitor fianlimab in advanced melanoma and an oral presentation on the primary analysis of a Phase 2 trial of Libtayo monotherapy in neoadjuvant cutaneous squamous cell carcinoma (CSCC). Other notable presentations include a late-breaking analysis from a Phase 3 trial investigating Libtayo in combination with chemotherapy in NSCLC, as well as a mini-oral on final, Phase 3 overall survival results of Libtayo monotherapy in advanced cervical cancer.

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s oncology portfolio on Monday, September 12 at 14:00 CEST/8:00 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

Regeneron presentations at ESMO (Free ESMO Whitepaper):

Medicine

Abstract title

Abstract

Presentation
date/time

(all CEST)

Skin cancer

Libtayo

Neoadjuvant cemiplimab in patients with
stage II–IV CSCC: Primary analysis of a
Phase 2 study

#789O

Monday,
September 12

11:05 – 11:15

Libtayo

Phase 2 study of cemiplimab in patients
with advanced CSCC: Final analysis from
EMPOWER-CSCC-1 Groups 1, 2 and 3

#814P

Saturday,
September 10

09:00 – 17:00

Libtayo

Phase 2 confirmatory study of cemiplimab
in patients with locally advanced or
metastatic CSCC: Study 1540 Group 6

#818P

Saturday,
September 10

09:00 – 17:00

Libtayo

CemiplimAb-rwlc Survivorship and
Epidemiology (CASE): A prospective|
study of the safety and efficacy of
cemiplimab in patients with advanced
CSCC in a real-world setting

#825P

Saturday,
September 10

09:00 – 17:00

Fianlimab, Libtayo

Phase 1 study of fianlimab, a human
lymphocyte activation gene-3 (LAG-3)
monoclonal antibody, in combination with
cemiplimab in advanced melanoma

#790MO

Monday,
September 12

08:35 – 08:40

Vidutolimod

Vidutolimod + pembrolizumab as 2L+
treatment in patients with anti-PD-1
refractory melanoma and adrenal
insufficiency: subgroup analyses of a
tudy

#845P

Saturday,
September 10

09:00 – 17:00

Ovarian cancer

Ubamatamab

Ubamatamab (REGN4018, MUC16xCD3
bispecific antibody) monotherapy in
patients with recurrent ovarian cancer:
Phase 1 dose-escalation analysis

#523MO

Saturday,
September 10

09:25 – 09:30

Lung cancer

Libtayo

Cemiplimab with platinum-based
chemotherapy for first-line locally
advanced NSCLC: EMPOWER-Lung 3
subgroup analysis

#954P

Saturday,
September 10

09:00 – 17:00

Libtayo

Clinical interchangeability of PD-L1
immunohistochemistry assays
for the treatment of first-line NSCLC with
cemiplimab

#114P

Saturday,
September 10

09:00 – 17:00

Libtayo

Continued cemiplimab with addition of
chemotherapy in patients with progressive
disease after first-line cemiplimab
monotherapy for advanced NSCLC:
analysis from EMPOWER-Lung 1

LBA54

Sunday,
September 11

15:37-15:47

Libtayo

Patient-reported outcomes of cemiplimab
vs chemotherapy in advanced NSCLC:
EMPOWER-Lung 1 histology subgroups

#1183P

Monday,
September 12

09:00 – 17:00

Libtayo

Factors associated with not receiving first-
line immune checkpoint inhibitor
treatment among patients with advanced
NSCLC and high PD-L1 expression: an
evaluation by age

#1149P

Monday,
September 12

09:00 – 17:00

Libtayo

Outcomes of real-world patients with
advanced NSCLC and high PD-L1
expression receiving first line immune
checkpoint inhibitor therapy

#1105P

Monday,
September 12

09:00 – 17:00

REGN5093

Early safety, tolerability, and efficacy of
REGN5093 in patients with MET-altered
advanced NSCLC from a first in human
study

#1173P

Monday,
September 12

09:00 – 17:00

Cervical cancer

Libtayo

Phase 3 EMPOWER-Cervical 1/GOG-3
016/ENGOT-cx9 trial of cemiplimab in
recurrent or metastatic cervical cancer:
Long-term survival analysis

#519MO

Saturday,
September 10

08:30 – 08:35

Blood cancer

N/A

Real-world health-related quality of life in
patients with Follicular Lymphoma:
Comparisons by line of therapy and
region (Europe vs US)

#634P

Sunday,
September 11

09:00 – 17:00

The potential uses of Libtayo, REGN5678, REGN5093, fianlimab, ubamatamab and vidutolimod described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority.

About Regeneron in Oncology
At Regeneron, we’re applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.

If you are interested in learning more about our clinical trials, please contact us ([email protected] or 844-734-6643) or visit our clinical trials website.

About Libtayo
Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Canada and Brazil.

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:

– A type of skin cancer called advanced CSCC that has spread or cannot be cured by surgery or radiation.

– A type of skin cancer called BCC:

That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with an HHI.
That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
– A type of lung cancer called NSCLC. Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK "or "ROS1" gene.

It is not known if Libtayo is safe and effective in children.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:
– have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
– have received an organ transplant
– have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
– have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Libtayo can harm your unborn baby
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
– are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at
1-877-542-8296.

On September 3, 2022 Yingli Pharma (the "Company" or "Yingli"), a clinical stage biotechnology company developing oral small molecule drugs for cancers with high unmet need, reported that the first patient has been dosed in a Phase 2 trial evaluating linperlisib, a potent inhibitor of the delta isoform of PI3 kinase (PI3Kδ) in patients with relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL) (Press release, Yingli Pharmaceutical, SEP 3, 2022, View Source [SID1234618977]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center. Additional trial sites will include medical centers in the United States and Italy.

"We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL," said Michael Hui, MBA, chief executive officer of Yingli. "Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions. We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib’s potential in this Phase 2 study."

"Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we’re excited to continue studying the drug’s potential as we start the Phase 2 study."

Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival. This Phase 2 (NCT05274997), single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with r/r PTCL who have failed at least one prior line of systemic therapy. Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters. An estimated 97 patients will be enrolled in the study.

About Linperlisib

Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, encouraging anti-tumor activities and promising PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A Phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended Phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to a Phase 2 study in follicular lymphoma (FL) that was completed and submitted in 2021 to China marketing authority for approval. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL and T cell lymphoma. Multiple linperlisib clinical trials in FL, PTCL, other lymphomas, solid tumors, combination with gemcitabine/oxaliplatin in r/r DLBC and combination with therapeutic PD1 antibody are underway in China. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma.

On September 2, 2022 Artificial intelligence (AI) biotech company Owkin reported that two first-in-class rapid, affordable AI-based diagnostic solutions designed to improve outcomes for patients with breast cancer and colorectal cancer have been approved for use in Europe (Press release, Owkin, SEP 2, 2022, https://www.fiercebiotech.com/medtech/owkins-ai-identify-breast-colorectal-cancers-scores-eu-approval [SID1234619036]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Owkin Dx RlapsRisk BC and Owkin Dx MSIntuit CRC have received CE-IVD approval for diagnostic use in the European Union. By using AI to analyze digital pathology images, they are designed to help clinicians make precision medicine – diagnostic and treatment based on a patient’s individual characteristics – more accessible to more patients at an earlier stage of their disease.

RlapsRisk BC is the first CE-IVD approved digital pathology-based AI diagnostic that predicts the risk that early breast cancer patients will relapse. MSIntuit CRC is the first CE-IVD approved AI solution that enables the identification of microsatellite stable (MSS) patients from routine histology slides, enabling a significant reduction in time and the number of diagnostic tests for detecting MSI in clinical practice.

These are the first approved diagnostics products developed by Owkin, which aims to develop more biomarker pre-screening and outcome prediction diagnostics across a range of disease areas. Owkin’s mission is to join patient care with medical research to discover new mechanisms of diseases and derive better treatments for unmet medical needs.

Meriem Sefta, Chief Diagnostics Officer at Owkin, said:

Our mission is to use AI to find the right treatment for every patient. Novel drugs allow us to personalize treatments to patients’ individual disease characteristics, promising a new era of precision medicine. But one roadblock that doctors face is finding these patients rapidly, accurately and efficiently.

Our first approved diagnostic solutions could help millions of patients with breast or colorectal cancer to receive the therapies they need sooner. This is a crucial moment in Owkin’s mission to use AI to better understand diseases and develop more accurate diagnostics and treatments for patients.

Owkin Dx RlapsRisk BC

RlapsRisk BC is an AI prognostic solution that predicts whether a breast cancer patient (ER+/HER2-) will go on to relapse after treatment, informing oncologists which high-risk patients may benefit from targeted therapies and which low-risk patients could potentially avoid chemotherapy.

The solution aims to revolutionize breast cancer care management by using AI to assess the risk of relapse after treatment from digital images of tissue samples. Currently, breast cancer patients at risk of relapse are identified through expensive, time-consuming molecular or genetic testing. RlapsRisk BC offers doctors a way to identify patients at risk of relapsing by using AI on digital pathology data that will already be held on nearly all breast cancer patients in around 15 minutes.

Dr Magali Lacroix-Triki, MD, PhD, an expert breast pathologist at the Department of Medical Biology and Pathology, Institut Gustave Roussy, Paris, said:

Owkin’s RlapsRisk BC enables pathologists to provide oncologists and patients with insights on the risk of relapse, crucial information for the treatment decision-making to avoid unnecessary chemotherapy. Thanks to RlapsRisk, HER2-, ER+ patients will benefit from an automated and accurate prognosis test using just a simple, standard-stained tumor slide.

AI-based digital pathology diagnostics could help us to provide a comprehensive analysis of each tumor from just one representative standard-stained tumor slide, in a complementary process to the pathologist’ diagnosis. This would democratize access to precision medicine, unlocking a new era of treatment for patients across the world.

Caption: RlapsRisk BC provides an interpretability report to the pathologist with a risk score, derived from the most predictive regions of the histology slide. Image shown may represent the range of the product, or be for illustration purposes only and may not be an exact representation of the product.

It offers comparable performance to standard molecular testing, yet uses far more readily-accessible data, reducing turnaround time and democratizing access to precision medicine.

RlapsRisk BC was developed with Gustave Roussy after winning the 2019 "AI for Health” challenge grant from Region Île de France. Its corresponding research has been presented at ESMO (Free ESMO Whitepaper) 2021 and USCAP 2022.

Owkin Dx MSIntuit CRC

MSIntuit CRC is an AI digital pathology diagnostic solution that pre-screens for a biomarker in colorectal cancer tumors known as microsatellite instability (MSI) – a defect in a cell’s ability to correct mistakes that occur when DNA is copied. This diagnostic rules out microsatellite stable (MSS) phenotypes, allowing pathologists to concentrate their resources on confirming those patients who exhibit MSI.

By using an AI model to analyze digital images of tissue samples, doctors are able to more efficiently screen patients when compared to standard testing techniques, which include time and patient tissue sample-consuming polymerase chain reaction (PCR) testing or immunohistochemistry.

Professor Magali Svrcek, MD, PhD, Sorbonne Université, AP-HP, Saint-Antoine Hospital, Department of Pathology, Paris, said:

As colorectal cancer is the third most common cancer in the world, it is crucial that we are able to screen patients for biomarkers that make them eligible for potentially lifesaving treatments. dMMR/MSI screening should be performed on all colorectal cancer patients, but pathologists’ time and resources are often too stretched.

Owkin’s new AI diagnostic solution MSIntuit CRC will roughly half the number of cases requiring screening. It is designed to help more patients receive treatment sooner. AI-based digital pathology algorithms like these, developed in consultation with pathologists, will soon become an integral part of our daily practice. They will help patients to benefit from the best treatment for them sooner – a new era of personalized medicine.

Patients with MSI-high tumors are eligible for treatment with the novel immunotherapy drug pembrolizumab, which a 2020 clinical trial found led to significantly longer progression-free survival than standard treatment when received as first-line therapy for MSI-H–dMMR metastatic colorectal cancer.

MSIntuit CRC provides an interpretability report to the pathologist, in which the most predictive regions found by the model on the histology slide are outlined.

MSIntuit CRC will help clinicians to gain accurate insights into patients’ individual needs at an earlier stage, enabling a precision medicine approach to treatment. By ruling out those patients who would not benefit from immunotherapy, MSIntuit CRC introduces a pre-screening step which saves pathologists’ and oncologists’ time and resources. Such an optimization supports the scaling of MSI screening for more patient populations and further disease indications.

MSIntuit was created by using deep learning – a type of AI that replicates how the human brain gains knowledge – on hundreds of patient samples until it could accurately detect the presence of MSI on images of tumors. Its accuracy has been validated by a clinical blind validation study on hundreds more patient samples.

On September 2, 2022 Jacobio Pharma (1167.HK) reported it has completed first patient dosage of it’s in-house R&D drug candidate CD73 monoclonal antibody JAB-BX102 in a Phase I/IIa clinical trial for advanced solid tumour patients (Press release, Jacobio Pharmaceuticals, SEP 2, 2022, View Source [SID1234618956]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This is a phase I/IIa multi-center, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of anti-tumor activity of JAB-BX102 monotherapy and combination with Pembrolizumab in adult patients with advanced solid tumors.

JAB-BX102 is Jacobio’s first big molecule program entered into the clinical stage. "The landscape of cancer treatment has been more and more complicated, combination therapies between different modalities are needed. Jacobio’s pipeline focuses on the unmet clinical needs and aims to bring hope to more patients through the in-house combination therapies. As an important Immune Oncology target, CD73 has the potential to be used in combination with multiple immuno-oncological therapies, such as PD-1/PD-L1 antibody and STING agonist, so as to relieve the immunosuppression of tumor microenvironment, stimulate the proliferation and activation of immune effector cells, enhance tumor immunity and play a synergistic role. Jacobio is developing CD73 STING iADC JAB-X1800." Said Dr. Yinxiang Wang, Chairman and CEO of Jacobio.

JAB-BX102 is a humanized monoclonal antibody, anti-CD73. CD73 is a protein that plays a key role in the adenosine pathway, and its inhibition has broad therapeutic potential for tumors that are reliant on an active adenosine pathway. Combination treatment of JAB-BX102 with immune checkpoint drugs such as PD-(L)1 (anti-PD-1, or anti-PD-L1) antibodies, can result in synergistic anti-tumor efficacy. There are no anti-CD73 antibodies currently approved for cancer therapy. Pre-clinical data suggest that JAB-BX102 has a dose-activity advantage and has the potential to benefit patients with solid tumors.