Gilead-Kite Oncology to Present Transformative Science From Growing Portfolio at ASCO 2021

On May 19, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that 16 abstracts representing the breadth of the Gilead-Kite Oncology portfolio will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Gilead Sciences, MAY 19, 2021, View Source [SID1234580305]). The abstracts, including two oral presentations, expand on the clinical profiles of Gilead’s antibody-drug conjugate (ADC), as well as Kite’s chimeric antigen receptor (CAR) T-cell therapies across a range of cancers, including in existing indications and for investigational uses.

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"Gilead-Kite Oncology is rapidly advancing transformative science for people facing historically difficult-to-treat cancers," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Our first-in-class, TROP-2 directed ADC therapy is already having a meaningful impact for people with metastatic triple-negative breast and urothelial cancers, and data at ASCO (Free ASCO Whitepaper) will add further insight into its utility in TNBC in both monotherapy and future combination treatment approaches."

"CAR T-cell therapy has changed the lives of patients suffering from certain forms of non-Hodgkin lymphoma, and our data at ASCO (Free ASCO Whitepaper) demonstrate important progress in extending the benefits to more patients in need," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "As we aim to bring CAR T to people with many different hematologic malignancies, we are just beginning to scratch the surface of what is possible."

A list of accepted abstracts follows here:

Abstract Disposition

Abstract Title

Gilead Presentations

Oral #1011

6:00 am PT/9:00 am ET

Outcomes in Patients Aged ≥65 Years in the Phase 3 ASCENT Study of Sacituzumab Govitecan (SG) in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1077

Assessment of Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) Cohort by Agent in the Phase 3 ASCENT Study of Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1080

Assessment of Sacituzumab Govitecan (SG) in Patients with Prior Neoadjuvant/Adjuvant Chemotherapy in the Phase 3 ASCENT Study in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS602

Phase 3 Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-Negative Breast Cancer Patients with High Relapse Risk After Standard Neoadjuvant Treatment – SASCIA

Poster #TPS1102

Saci-IO HR+: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1+ Hormone Receptor-Positive (HR+) / HER2- Metastatic Breast Cancer (MBC)

Poster #TPS1106

Saci-IO TNBC: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1– Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS7055

Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher Risk Myelodysplastic Syndrome (MDS): The Phase 3, Randomized, ENHANCE Study

Poster #2559

GS-3583, a Novel FLT3 Agonist Fc Fusion Protein, to Expand Conventional Dendritic Cells in Healthy Volunteers

Poster #TPS3147

Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors

Kite Presentations

Oral #7002

11:30 am PT/2:30 pm ET

Phase 2 Results of the ZUMA-3 Study Evaluating KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)

Poster #7515

Outcomes in ZUMA-5 with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) Who Had the High-Risk Feature of Progression within 24 Months from Initiation of First Anti-CD20–Containing Chemoimmunotherapy (POD24)

Poster #7536

Favorable Tumor Immune Microenvironment (TME) and Robust Chimeric Antigen Receptor (CAR) T-Cell Expansion May Overcome Tumor Burden and Promote Durable Efficacy with Axicabtagene Ciloleucel (Axi-Cel) in Large B Cell Lymphoma (LBCL)

Poster #7547

Outcomes with KTE-X19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma (MCL) in ZUMA-2 Who Had Progression of Disease within 24 Months of Diagnosis (POD24)

Poster #7548

Updated Outcomes with Axicabtagene Ciloleucel (Axi-Cel) Retreatment in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) in ZUMA-5

Poster #7552

Real-World Evidence of Axicabtagene Ciloleucel (Axi-Cel) for the Treatment of Large B-Cell Lymphoma (LBCL) in the United States

Poster #e19548

Online Publication Only

Clinical Outcomes in Patients Relapsed/Refractory After ≥ 2 Prior Lines of Therapy for Follicular Lymphoma: A Systematic Literature Review and Meta-Analysis

All poster presentations will be made available on-demand beginning Friday, June 4 at 6:00 am PT/9:00 am ET.

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

Jasper Therapeutics Announces Updated 90-day Data from Phase 1 Clinical Trial of JSP191 as Targeted Stem Cell Conditioning Agent in Older Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation

On May 19, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported updated 90-day efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the company’s first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation (Press release, Jasper Therapeutics, MAY 19, 2021, View Source [SID1234580304]). Data from the dose-finding part of the study showed that conditioning with a single dose of JSP191 0.6 mg/kg prior to low dose radiation and fludarabine in preparation for transplantation was well tolerated in all six patients and led to successful transplant as evidenced by full chimerism and elimination of measurable residual disease (MRD) in five of six patients. The findings will be presented by lead investigator Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine, in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held online from June 4-8. The abstract is available now on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

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"We are very encouraged by the updated efficacy and safety results from this Phase 1 clinical study, which is the first to evaluate JSP191 in combination with non-myeloablative conditioning for older patients with MDS or AML. These data are consistent with pre-clinical work that demonstrated the capacity of JSP191 to target myelodysplastic cells and synergize with low doses of radiation. While hematopoietic cell transplantation is curative in these patients, its use is limited in older and frail patients because of the toxicity associated with standard-of-care myeloablative conditioning agents," said Kevin N. Heller, M.D., Executive Vice President, Research and Development, of Jasper Therapeutics. "Based on this data and feedback from the FDA, we have now opened the dose-expansion phase of the study at the recommended Phase 2 dose. We anticipate announcing topline data in the first half of next year. We continue to evaluate JSP191 as a conditioning agent in multiple additional diseases, including our ongoing clinical trial in severe combined immunodeficiency (SCID), our upcoming study in refractory autoimmune disease and with our partnerships with the NIH and Stanford in sickle cell disease and Fanconi anemia. We believe that JSP191 addresses key limitations of current conditioning regimens and potentially may expand the number of patients with devastating diseases who could be cured with hematopoietic stem cell therapy."

At 90 days after transplant, MRD as measured by cytogenetics, karyotype and next-generation sequencing was negative (undetected) in five patients and reduced in one patient, and full chimerism (greater than 95%) was observed in five of the six patients. One patient had secondary graft failure with no evidence of relapse at 90 days. JSP191, when added to low-dose radiation and fludarabine, was well tolerated in all six patients; the protocol allows for subjects to receive the conditioning regimen in an outpatient setting. No infusion reactions, treatment-related toxicities such as oral mucositis or evidence of acute graft versus host disease were reported. Pharmacokinetic data showed that serum levels of the JSP191 0.6 mg/kg dose were consistent among study participants as evaluated up to 14 days post-infusion.

Phase 1 Study Design

The open-label, multicenter Phase 1 study (JSP-CP-003) is evaluating the safety, tolerability and efficacy of adding JSP191 to the standard conditioning regimen of low-dose radiation and fludarabine among patients age 65 to 74 years with MDS or AML undergoing hematopoietic cell transplantation. Patients were ineligible for full myeloablative conditioning. The primary outcome measure of the study is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant. Secondary endpoints include engraftment and donor chimerism, MRD clearance, non-relapse mortality, event-free survival and overall survival.

About MDS and AML

Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.i Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Jasper is currently enrolling in two clinical trials for acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS) and severe combined immunodeficiency (SCID) and expects to begin enrollment in three additional studies in 2021 for severe autoimmune disease, sickle cell disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

ImmunoGen Announces Mature Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status

On May 19, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate (Press release, ImmunoGen, MAY 19, 2021, View Source [SID1234580303]). These findings will be highlighted in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, which is being held June 4-8, 2021. Two posters highlighting mirvetuximab combination regimens will also be presented by ImmunoGen’s collaborators during the meeting.

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"Due to the introduction of effective maintenance therapies, patients with recurrent ovarian cancer are living longer and comprise an increasing population in need of effective, well-tolerated non-platinum based regimens," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS, the combination of mirvetuximab plus bevacizumab shows compelling activity in patients with high FRα recurrent ovarian cancer. We are extremely pleased to present these data during an oral presentation at ASCO (Free ASCO Whitepaper), as they build on previous findings and provide us with further evidence of mirvetuximab’s potential to become the combination agent of choice for ovarian cancer patients."

MATURE DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB

The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy (range 1-4). 53% had platinum-resistant disease with a platinum-free interval (PFI) of less than or equal to 6 months; 33% had partially platinum-sensitive disease with a PFI greater than 6 months and less than or equal to 12 months; and 13% had a PFI greater than 12 months. 40% of patients in the cohort were previously treated with bevacizumab and 35% of patients in the cohort were previously treated with a PARP inhibitor. The combination of mirvetuximab with bevacizumab in this cohort demonstrates promising anti-tumor activity with a favorable tolerability profile, particularly among patients with high levels of FRα expression, and is encouraging relative to outcomes with available therapies reported in similar populations. In the oral presentation, key updated data include:

In the overall patient population, objective responses were seen in 30 patients and the confirmed overall response rate (ORR) was 50% (95% CI, 34, 60), with a median duration of response (mDOR) of 9.7 months (95% CI 6.7, 12.9) and median progression-free survival (mPFS) of 8.3 months (95% CI 5.6, 10.1).
In patients with high FRα expression (n=33), the confirmed ORR was 64% (95% CI, 45, 80), mDOR was 11.8 months (95% CI 6.7, 13.7), and mPFS was 10.6 months (95% CI 8.3, 13.3).
In high FRα platinum-sensitive patients, who represent a growing population, the combination of mirvetuximab plus bevacizumab achieved a 69% ORR, 12.7 month mDOR, and a 13.3 month mPFS.
In high FRα platinum-resistant patients, the combination of mirvetuximab plus bevacizumab achieved a 59% ORR, 9.4 month mDOR, and a 9.7 month mPFS.
The adverse events (AEs) observed with the doublet were manageable and consistent with the side effect profiles of each agent. Treatment-related AEs were generally low grade, with diarrhea (62%), blurred vision (60%), fatigue (60%), and nausea (57%) being the most common. The most common grade 3+ events were hypertension (17%) and neutropenia (13%).
"Despite advances in the maintenance setting of ovarian cancer, a high unmet need for novel, well-tolerated, targeted treatments exists in those patients with recurrent high-grade epithelial ovarian cancer," said David O’Malley, MD, Professor, Director of Gynecologic Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at The Ohio State University and the James Cancer Center, and FORWARD II Principal Investigator. "The data we continue to see when mirvetuximab is combined with bevacizumab in recurrent disease are extremely encouraging, particularly in light of outcomes reported with available therapies in even less heavily pre-treated populations. The strength of these mature data warrant further development of this novel, targeted combination and I look forward to evaluating this regimen in earlier lines of therapy."

ORAL PRESENTATION SESSION

Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer – Final Analysis"
Day/Time: Monday, June 7 from 8:00 a.m. to 11:00 a.m. ET
Lead Author: David M. O’Malley, MD, The Ohio State University College of Medicine
Abstract: 5504
POSTER SESSIONS

The following posters will be available on Friday, June 4 at 9:00 a.m. ET in the ASCO (Free ASCO Whitepaper) Meeting Library:

Title: "A Phase I Study of Mirvetuximab Soravtansine and Gemcitabine in Patients with FRα-Positive Solid Tumors: Results from the Ovarian Cancer Cohort"
Lead Author: Mihaela C. Cristea, MD, City of Hope National Medical Center
Abstract: 5542
Title: "A Phase 2, Two-Stage Study of Mirvetuximab Soravtansine in Combination with Pembrolizumab in Patients with Microsatellite Stable Endometrial Cancer"
Lead Author: Rebecca L. Porter, MD, PhD, Dana-Farber Cancer Institute
Abstract: TPS5611
Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

Pivotal Phase III Data at ASCO Show Genentech’s Tecentriq Helps Certain People With Early Lung Cancer Live Significantly Longer Without Their Disease Returning

On May 19, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumors express PD-L1≥1%, compared with best supportive care (BSC) (Press release, Genentech, MAY 19, 2021, View Source [SID1234580302]). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.

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In the larger population of all randomized Stage II-IIIA study participants, Tecentriq reduced the risk of disease recurrence or death by 21% (HR=0.79, 95% CI: 0.64-0.96) after a median follow-up of 32.2 months. In this population, Tecentriq increased DFS by a median of seven months (42.3 months vs. 35.3 months with BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. The full results of IMpower010 will be presented in the lung cancer oral abstract session (Abstract #8500) on Sunday, June 6 (8:00 AM – 11:00 AM EDT) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

"These landmark Phase III data demonstrate for the first time that cancer immunotherapy can bring a clinically meaningful improvement to certain people with early lung cancer in the adjuvant setting," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "These results lay the groundwork for a new approach to the treatment of early-stage lung cancer and bring us closer to our goal of providing an effective and tailored treatment option for every person diagnosed with this disease."

The goal of adjuvant therapy is to lower the risk of recurrence and provide the best opportunity for a cure. Still, about half of all patients with Stage I-III NSCLC eventually develop disease recurrence following curative-intent treatment. Adjuvant platinum-based chemotherapy is the current standard of care for patients with completely resected early-stage NSCLC (Stage IB-IIIA) who are at a high-risk of disease recurrence or relapse. This treatment provides a modest 4-5% improvement in five-year survival compared with observation.

Follow-up will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, including Stage IB patients, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. In the overall randomized population of study participants, adverse events (AEs) occurred in 92.7% of people receiving Tecentriq, compared with 70.7% of those receiving BSC. Grade 3 or 4 events occurred in 21.8% of people treated with Tecentriq compared with 11.5% in the BSC group; 0.8% of people in the Tecentriq group experienced a Grade 5 AE. As anticipated, the addition of up to one year of Tecentriq following chemotherapy led to a higher number of AEs compared with BSC.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in the U.S. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.

About the IMpower010 study

IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

Efficacy results

PD-L1≥1% Stage II-IIIA

Randomized Stage II-IIIA

ITT

Tecentriq (n=248)

BSC (n=228)

Tecentriq (n=442)

BSC (n=440)

Tecentriq (n=507)

BSC (n=498)

Median DFS (months)

NR

35.3

42.3

35.3

NR

37.2

Stratified HR (95% CI)

0.66 (0.50, 0.88)

0.79 (0.64, 0.96)

0.81 (0.67, 0.99)*

Stratified Log-rank p-value (2-sided)

0.004

0.02

0.04

NR, Not reached

* Did not cross significance boundary

Safety results

Tecentriq

BSC

All Grade AEs

92.7%

70.7%

Grade 3-4 Events

21.8%

11.5%

Grade 5 treatment-related AEs

0.8%

n/a

AEs leading to treatment withdrawal

18.2%

n/a

About lung cancer

According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021, and NSCLC accounts for 80-85% of all lung cancers. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery, but treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as their first treatment when their lung cancer:
has spread or grown, and
their cancer tests positive for "high PD-L1", and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may also be used when their lung cancer:
has spread or grown, and
they have tried chemotherapy that contains platinum, and it did not work or is no longer working
if their tumor has an abnormal "EGFR" or "ALK" gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
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
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of the skin or the whites of the eyes
severe nausea or vomiting
pain on the right side of their stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches 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
their voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in their amount of urine
blood in their urine
swelling of their ankles
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
swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

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, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
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 patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

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 received radiation treatment to their chest area
have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
nausea
cough
shortness of breath
decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or View Source Report side effects to Genentech at 1-888-835-2555.

Please see View Source for full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

Aumolertinib Significantly Prolongs Progression-Free Survival with Fewer Side Effects in the First-Line Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

On May 19, 2021 EQRx reported that Detailed results from the Phase III AENEAS trial showed that treatment with aumolertinib resulted in a clinically significant improvement in progression-free survival (PFS) as compared to gefitinib in first-line treatment of patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with the most common types of EGFR mutations (Press release, EQRx, MAY 19, 2021, View Source [SID1234580301]). In addition, the encouraging safety findings of less frequent rash and diarrhea confirmed the previously reported findings in the second-line APOLLO study. Aumolertinib is already approved in China in the second-line setting and is being jointly developed by EQRx and Hansoh Pharma globally.

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"These Phase III results are compelling as we work to continuously improve the patient experience through innovative treatments. We look forward to working with EQRx to bring aumolertinib to more patients with advanced lung cancer in China and around the world."

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These results will be discussed in a Poster Discussion Session during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Virtual Annual Meeting on June 4, 2021 (abstract #9013).

Hansoh Pharma and EQRx have partnered to expand global access to aumolertinib and plan to pursue regulatory discussions in multiple countries. The Companies will continue investigation of applications for aumolertinib across a variety of monotherapy and combination trials that are ongoing or planned.

"EGFR TKIs are the standard of care for treating EGFR-mutant NSCLC. Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability," commented Vincent Miller, M.D., physician-in-chief of EQRx. "At EQRx, our focus is to ensure that more patients have access to and can benefit from the latest innovative medicines, starting with oncology—one of the disease areas with the highest cost burden for treatments. Our mission is closely aligned with this year’s ASCO (Free ASCO Whitepaper) focus on equity, and these results are a significant step toward our goal of more equitable access to medicine."

"We’re excited to build upon the success of this therapy in the second-line setting with the potential for patients to benefit from aumolertinib now also in the first-line setting," said Aifeng Lyu, Ph.D., president of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., a subsidiary of Hansoh Pharma. "These Phase III results are compelling as we work to continuously improve the patient experience through innovative treatments. We look forward to working with EQRx to bring aumolertinib to more patients with advanced lung cancer in China and around the world."

AENEAS is a double-blind randomized phase III trial comparing aumolertinib 110 mg once daily (n=214) to gefitinib 250 mg once daily (n=215) in patients with EGFR-mutated NSCLC. AENEAS met its primary endpoint of prolongation of PFS at the time of the pre-specified event driven analysis. The median PFS was estimated at 19.3 months for aumolertinib and 9.9 months for gefitinib with a hazard ratio 0.46 (p<0.0001). At a landmark one-year analysis, 69 percent of patients treated with aumolertinib were free of disease progression compared to 46 percent of patients treated with gefitinib. Improvement in PFS in patients who received aumolertinib over gefitinib was observed across relevant subgroups of patients, including those with brain metastases. The study has not yet met the cutoff for overall survival.

Aumolertinib was well-tolerated. Adverse events that caused patients to temporarily stop or discontinue treatment altogether were less common with aumolertinib than with gefitinib. Aumolertinib was associated with lower incidence of commonly observed EGFR-related adverse events of rash and diarrhea and no new safety signals were identified. These results further suggest aumolertinib to be an excellent choice for combination studies and studies in the adjuvant setting in this subset of patients with NSCLC.

ABOUT AUMOLERTINIB

Aumolertinib (proposed INN, formerly almonertinib) 110 mg once-daily tablet is a medicine approved in China as AMEILE for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by a genomic test, who have progressed on or after prior EGFR TKI therapy. Aumolertinib has demonstrated high potency and nanomolar inhibitory activity against common EGFR mutations, as well as drug-resistant T790M mutations.

Aumolertinib is a novel, irreversible EGFR-TKI that selectively inhibits both EGFR sensitizing and resistance mutations with high selectivity over wild-type EGFR. The agent was approved in China in March 2020 based on a large single arm Phase II study entitled APOLLO in second-line settings. Based on these results, the Phase III AENEAS trial was initiated.

Hansoh Pharma and EQRx have partnered to expand global access to aumolertinib.