Indica Labs achieves CE-IVD certification for AI-based Prostate Cancer Detection and Gleason Grading Tool

On May 24, 2022 Indica Labs, the leading provider of computational pathology software and services, reported a CE-IVD Mark for HALO Prostate AI, a deep learning-based screening tool designed to assist pathologists in identifying and grading prostate cancer in core needle biopsies (Press release, Indica Labs, MAY 24, 2022, View Source [SID1234614970]).

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

                  Schedule Your 30 min Free Demo!

Prostate cancer is the most common cancer diagnosed in men. With over 1.4 million cases reported worldwide in 2020, the incidence rates continue to rise with wider availability of screening tests, such as PSA. Each prostate case consists of multiple biopsy core whole slide images, which must be assessed by a pathologist for the presence of tumor and, if present, a Gleason score is reported. This represents a large workload for pathologists who screen multiple cases daily. HALO Prostate AI is designed to work alongside the pathologist to improve efficiency and to add a layer of quality control to ensure diagnostic accuracy.

Developed in close collaboration with Dr. Yuri Tolkach and colleagues from the University of Cologne, HALO Prostate AI was trained using over 870,000 training patches obtained from the annotation of digital scans representing the full spectrum of prostate cancer subtypes and Gleason grades, as well as benign tissue. The algorithm achieved high sensitivity (95- 100%), specificity (88-98%) and negative predictive value (98- 100%) in validation studies performed on 4,973 core needle biopsies from three independent cohorts sourced from hospitals in Austria and Germany. Highlighting the unique benefit of HALO Prostate AI screening on diagnostic accuracy and patient care, the algorithm correctly detected tumor in 26 cores within the validation study that were originally reported as tumor negative.

In a separate study, Gleason scores obtained from HALO Prostate AI were compared against scores assigned by pathologists located in ten globally distributed hospitals. Nine pathologists who participated in the study were board-certified in genitourinary pathology. High concordance was achieved for two separate cohorts with representative average quadratic Kappa scores of 0.8 and 0.7.

"I am very excited about the digital future of pathology," commented Dr. Tolkach. "With tools such as HALO Prostate AI, our work can be substantially optimized while controlling for high-quality, reliable, and objective diagnostics. HALO Prostate AI showed very high accuracy in the large multi-institutional study for tumor detection and Gleason Grading in prostate biopsies. It’s really enjoyable to work back-to-back with such a powerful AI assistant".

Dr. Peter Caie, Principal Scientist of AI Collaboration at Indica Labs, added, "This has been a hugely positive collaboration with Dr. Tolkach and contributing pathologists from around the world. We set out to build a clinical-grade algorithm that could improve turn-around time and diagnostic accuracy for prostate cancer patients, and I believe that is exactly what we have achieved. We are thrilled to see the first of many AI algorithms from Indica Labs attain CE-IVD marking and to begin to be used in clinical settings to help alleviate the pressure of ever-increasing workloads."

HALO Prostate AI is deployed through Indica Labs’ CE-IVD marked HALO AP platform to provide a fully validated and automated end-to-end workflow. HALO AP can operate as a fully functional, standalone case management system or can integrate with existing LIS solutions to allow outputs from HALO Prostate AI or other AI diagnostics to be accessible directly from the LIS. Designed to be scanner agnostic, HALO Prostate AI was trained using digital scans obtained from multiple scanning platforms and was clinically validated against the Hamamatsu NanoZoomer S360 and Leica GT450 platforms.

Pierre Fabre and EORTC open a large Phase III clinical study in the adjuvant setting of stage IIB-C melanoma

On May 24, 2022 Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) reported the screening of the first patient with a resected stage II BRAF-mutant melanoma for the phase III study COLUMBUS-AD (NCT05270044; EORTC-2139-MG) (Press release, EORTC, MAY 24, 2022, View Source [SID1234614969]).

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

                  Schedule Your 30 min Free Demo!

COLUMBUS-AD is a pioneering study to evaluate whether the combination of BRAF and MEK inhibitors encorafenib (Braftovi) and binimetinib (Mektovi) can prolong recurrence-free survival (RFS) and improve distant metastasis-free survival (DMFS) and overall survival (OS) as compared to placebo in participants with surgically resected stage IIB-C BRAF V600E/K-mutant cutaneous melanoma.

"Pierre Fabre’s partnership with EORTC is now accelerating with the opening of COLUMBUS-AD", said Dr Deborah Szafir, Executive Vice President, Head of Medical and Patient Consumer Division at Pierre Fabre. "Building on the clinical benefits that our medicines have demonstrated in advanced disease, we are eager for patients with a BRAF-mutated tumour to explore the adjuvant setting in an earlier stage of the disease as the unmet medical need remains high."

Despite the remarkable progress made in the treatment of advanced melanoma activating the BRAF mutation, unfortunately there remains a high unmet need in earlier stages of the disease. It is estimated that 18% of stage IIB and 25% of stage IIC patients die from melanoma within 10 years from diagnosis.

"The screening of patients for COLUMBUS-AD focuses on patients with surgically resected high-risk IIB-C BRAF V600E/K-mutant cutaneous melanoma", said study coordinator assoc. prof. Dr. Alexander C.J. Van Akkooi, MD PhD, from the Melanoma Institute Australia (MIA) and past chairman of the EORTC Melanoma Group. "It is essential to test the tumour as early as possible for BRAF mutation, so that eligible patients can get a chance to participate into COLUMBUS-AD".

Approximately 815 patients will be enrolled in COLUMBUS-AD. More than 160 sites in up to 25 countries worldwide will participate in the study.

Patients included in the study must have undergone resection of a stage IIB-C melanoma with a BRAF V600E/K mutation, confirmed on resected tumour sample by a central laboratory, and a negative result on sentinel node biopsy. Patients must also have fully recovered from the surgery, have a good performance status (ECOG 0/1), and adequate hematologic, hepatic, cardiac, coagulation and renal functions.

Patients will receive encorafenib and binimetinib or placebo for up to 12 months. They will be followed-up monthly during the treatment period, then every 3 months up to year 3, and then at regular intervals. The participants will be followed-up for 10 years in total.

Pierre Fabre has a long-standing commitment to the melanoma community and takes a unique holistic approach to skin health with expertise in oncology, dermatology and dermo-cosmetics. EORTC, a unique academic clinical research organisation uniting clinical cancer research experts across the globe, shares Pierre Fabre’s commitment to improving the standard of cancer treatment for patients.

About Melanoma

Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours.1 There are about 324,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.2,3,4 By 2025, the number of cases is expected to increase to over 340,000.5

BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2022

On May 24, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported its results for the first quarter 2022 (Press release, BerGenBio, MAY 24, 2022, View Source [SID1234614968]).

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

                  Schedule Your 30 min Free Demo!

A briefing by BerGenBio’s senior management team will take place at 10:00am CEST today via a webcast presentation, followed by a Q&A session. Please see below for details.

Operational Highlights – first quarter 2022 (including post-period end)

Post-period end, business strategy update announced, focusing on two key indications; 1st line STK11m non-small cell lung cancer (NSCLC) and COVID-19. ​
Primary endpoint met in hospitalized COVID-19 patients in complete data analysis of ACCORD2 (BGBIL019), a randomized Phase II study of bemcentinib in combination with standard of care therapy.
Presented clinical trial data from Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) at 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).​
Cristina Oliva, MD appointed as Chief Medical Officer, bringing over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and Clinical Research Organizations.
Publication of a peer-reviewed article entitled "AXL targeting restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through expansion of TCF1+ CD8+ T cells" in the journal Cell Reports Medicine.
Announced inclusion of bemcentinib, in the EUSolidAct platform study of hospitalized COVID-19 patients designed to enroll up to 500 patients across European centers participating in the EUSolidAct platform.
Financial Highlights – first quarter 2022

(Figures in brackets = same period 2021 unless otherwise stated)

Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the first quarter 2022
Total operating expenses for the first quarter were NOK 78.6 million (NOK 83.4 million)
The operating loss for the first quarter came to NOK 78.6 million (NOK 83.4 million)
Cash and cash equivalents amounted to NOK 367.8 million at the end of the first quarter 2022 (NOK 436.6 million by end of December 2021)
Martin Olin, Chief Executive Officer of BerGenBio, commented: "Earlier this month, we provided an update on the Company’s strategy. BerGenBio’s mission remains unchanged, and we believe that the announced focus provides an optimal path to unlock the potential of AXL inhibition as a transformative treatment modality for severe diseases.​

By focusing the development of our lead asset bemcentinib to two key areas, STK11 mutated (STK11m) 1st line non-small cell lung cancer (NSCLC) and COVID-19, we believe we have defined the path to efficiently advance BerGenBio’s clinical and commercial potential. Both indications represent significant unmet medical needs and our defined plans for each of these indications provides a strong foundation for bringing new drug to market with the aim of achieving better outcomes for patients and the generation of significant value for our shareholders.​

With a focused strategy and rightsized organization, I believe we are well positioned to unlock significant potential value related to the two indications selected and define the path to market."

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

Webcast link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220524_3

The first quarter report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

Data at the 2022 ASCO Annual Meeting Highlight Genentech’s Continued Commitment to Innovation in Oncology and Personalized Healthcare

On May 24, 2022 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 3-7, 2022 (Press release, Genentech, MAY 24, 2022, View Source [SID1234614958]). Genentech and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this year’s meeting.

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

                  Schedule Your 30 min Free Demo!

"At ASCO (Free ASCO Whitepaper) this year, progress from our portfolio, partnerships and collaborations showcase our commitment to advance innovation in cancer care," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We’re especially pleased to present data from our broad hematology portfolio, including pivotal data for glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with heavily pre-treated aggressive lymphoma."

Focusing on improving outcomes in non-Hodgkin lymphoma

New and updated data in non-Hodgkin lymphoma will be presented at ASCO (Free ASCO Whitepaper). This includes pivotal data from the Phase II NP30179 study investigating glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, where as many as 40% of patients will relapse, at which point treatment options are limited and survival is shortened. Glofitamab is part of Genentech’s broad bispecific antibody development program, which may offer a new immunotherapy-based approach to tackle a range of blood cancers. It is being investigated in several clinical trials including the STARGLO Phase III study, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in autologous stem-cell transplant ineligible relapsed or refractory DLBCL. In addition, key findings from an analysis of the Asia subpopulation from the pivotal Phase III POLARIX study investigating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with newly diagnosed DLBCL will be featured. Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in previously untreated DLBCL in more than 20 years, potentially transforming treatment for people with this disease.

Driving innovation in personalized cancer care

More than 20 new pieces of research from partnerships with Foundation Medicine will be presented, which continue to support innovation as well as progress in personalized cancer care. This includes new data from the Phase II Profiler02 study,* which investigates the use of a comprehensive genomic profiling testing panel from Foundation Medicine, with the aim of informing possible treatment decisions for patients based on their tumor’s unique genomic information.

Data from the imCORE network

Additionally, three abstracts from the Immunotherapy Centers Of Research Excellence (imCORE) Network will be presented at ASCO (Free ASCO Whitepaper): a Phase I study** investigating autogene cevumeran (an mRNA-based individualized neoantigen-specific immunotherapy [iNeST]***) in the adjuvant setting of pancreatic ductal adenocarcinoma; a data mining study** evaluating intermediate endpoints for survival in metastatic breast cancer in the real-world setting; and a study identifying mechanisms of acquired resistance to immune checkpoint blockade.**

imCORE is an academic-industry network for scientific collaboration. Established by Genentech and connecting experts from 26 leading institutions around the globe, imCORE is committed to advancing and accelerating cancer immunotherapy research. imCORE is an example of Genentech’s dedication to collaborating with the global cancer community to further understand cancer biology and immunology, help inform the development of potential future treatment, and transform patients’ lives.

Genentech’s data presented at ASCO (Free ASCO Whitepaper) will feature its efforts to drive innovation and commitment to health equity through delivery of pioneering medicines and personalized cancer care that together improve outcomes for every patient while reducing the cost to society, inclusive clinical trials that remove barriers to participation, partnerships that multiply our ability to address challenges in cancer care, and bringing innovation into earlier stages of disease to maximize a chance of cure.

Overview of key presentations featuring Genentech medicines

Medicine

Abstract title

Abstract number

Blood cancer

Glofitamab

Glofitamab in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and ≥2 prior therapies: Pivotal Phase II expansion results

#7500

Mosunetuzumab

CELESTIMO: a Phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma who have received ≥1 line of systemic therapy

#TPS7588

Polivy

Asia subpopulation analysis from the Phase III POLARIX trial

#7558

Initial safety run-in results of the Phase III POLARGO trial: polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL)

#7551

Lung cancer

Tiragolumab

SKYSCRAPER-02: primary results of a Phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo) plus carboplatin plus etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC)

#LBA8507

Breast cancer

Giredestrant

Neoadjuvant giredestrant (GDC-9545) plus palbociclib (P) versus anastrozole (A) plus P in postmenopausal women with estrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): final analysis of the randomized, open-label, international Phase 2 coopERA BC study

#589

Inavolisib

Long-term safety of inavolisib (GDC-0077) in an ongoing Phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib (palbo) and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer (BC)

#1052

Tumor agnostic treatment and personalized healthcare

Rozlytrek

Efficacy/safety of entrectinib in patients (pts) with ROS1-positive (ROS1+) advanced/metastatic NSCLC from the Blood First Assay Screening Trial (BFAST)

#LBA9023

Rozlytrek

Trial in progress: a randomized Phase 3 study of entrectinib vs crizotinib in patients (pts) with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC with or without baseline CNS metastases (mets)

#TPS9141

Comprehensive genomic profiling

(IIS, Centre Léon Bérard)

Increasing targeted therapy options for patients with relapsed cancer with broader somatic gene panel analysis from the primary tumor: The Profiler02 randomized Phase II trial*

#3130

Comprehensive genomic profiling

Clinical and genomic characteristics of patients with durable benefit from immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer (aNSCLC)

#9048

Comprehensive genomic profiling

ctDNA Shed as a Tool to Select Immune Checkpoint Inhibitors (ICPI) with or without Chemotherapy for Patients (pts) with advanced Non-small Cell Lung Cancer (aNSCLC)

#9045

Comprehensive genomic profiling

Trial in progress: LCMC LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers

#TPS8596

Real world data

A real world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD)

#8525

Real world data

Real world analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC)

#9123

Real world data

Ancestry-based differences in gene alterations in non-small cell lung cancer: real-world data using genetic ancestry analysis

#9125

imCORE,

ISR, Genentech

Identifying mechanisms of acquired immune escape from sequential, paired biopsies**

#2519

imCORE

ISR, Dana-Farber Cancer Institute

Real-World Progression-Free Survival (rwPFS) and Time to Next Line of Therapy (TTNT) as Intermediate Endpoints for Survival in Metastatic Breast Cancer: A Real World Experience**

#6520

imCORE

ISR, Memorial Sloan Kettering Cancer Center

Phase I Trial of Adjuvant Autogene Cevumeran, an Individualized mRNA Neoantigen Vaccine, for Pancreatic Ductal Adenocarcinoma**

#2516

* IIS, investigator-initiated study

** ISR, institution-sponsored research

*** jointly developed by Genentech and BioNTech

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns

Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion
Infections: Patients should contact their healthcare team if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with Polivy can cause severe low blood cell counts
Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication
Side effects seen most often

The most common side effects during treatment were:

Low blood cell counts (platelets, red blood cells, white blood cells)
Nerve problems in arms and legs
Tiredness or lack of energy
Diarrhea
Nausea
Fever
Decreased appetite
Infections
Polivy may not be for everyone. A patient should talk to their doctor if they are:

Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for at least 2 months after the last dose
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

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

Please visit View Source for the full Prescribing Information for additional Important Safety Information.

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 a treatment for their lung cancer:
to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
their cancer tests positive for "PD-L1".
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
decreased appetite
nausea
cough
shortness of breath
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 Rozlytrek

Rozlytrek (entrectinib) is an oral medicine for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC), as well as for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Rozlytrek can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.

Rozlytrek U.S. Indication (pronounced roz lye’ trek)

Rozlytrek is a prescription medicine used to treat:

Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene
Adults and children 12 years and older with solid tumors (cancer) that:
are caused by certain abnormal NTRK genes and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment
It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.

Rozlytrek was approved in NTRK gene fusion-positive solid tumors through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm benefit of Rozlytrek for this use.

Important Safety Information

Rozlytrek may cause serious side effects, including:

Congestive heart failure. Rozlytrek may cause congestive heart failure or make the congestive heart failure that a patient already has worse. Patients should tell their healthcare provider right away if they have any of the following signs and symptoms of congestive heart failure:

● persistent coughing or wheezing

● increasing shortness of breath


● trouble breathing when lying down

● tiredness, weakness, or fatigue


● sudden weight gain

● swelling in ankles, feet, or legs

Central nervous system (CNS) effects. Rozlytrek may cause dizziness, changes in mood, or may affect how a patient thinks and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Patients should tell their healthcare provider right away if they have any of these symptoms.
Bone fractures. Rozlytrek may increase the risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Patients should tell their healthcare provider if they have pain, changes in movement, or bone abnormalities.
Liver problems (hepatotoxicity). A healthcare provider will do blood tests to check a patient’s liver function during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of the stomach area. A healthcare provider may temporarily stop treatment, decrease the dose, or permanently stop Rozlytrek if a patient develops liver problems with Rozlytrek.
Increased uric acid level in the blood (hyperuricemia). Rozlytrek may cause an excess of uric acid in the blood. A healthcare provider may do tests before and during a patient’s treatment with Rozlytrek to check the uric acid level in the blood. A healthcare provider may prescribe medications if a patient has high blood uric acid levels.
Changes in the electrical activity of the heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. A healthcare provider will do tests before and during treatment with Rozlytrek to check the electrical activity of the heart and body salts (electrolytes). Patients should tell their healthcare provider right away if they feel faint, lightheaded, dizzy, or feel their heart beating irregularly or fast while taking Rozlytrek. These may be symptoms related to QT prolongation.
Vision problems. Rozlytrek may cause vision problems. Healthcare providers may stop Rozlytrek and refer to an eye specialist if a patient develops severe vision problems during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they have any loss of vision or any change in vision, including:

● double vision

● seeing flashes of light


● blurry vision

● light hurting the eyes


● new or increased floaters

Before taking Rozlytrek, patients should tell their healthcare provider about all their medical conditions, including if they:

have liver or kidney problems.
have any heart problems, including a condition called long QT syndrome.
have nervous system (neurological) problems.
have or have had eye or vision problems.
are pregnant or plan to become pregnant. Rozlytrek can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant during treatment with Rozlytrek or think they may be pregnant.
If patients are able to become pregnant, their healthcare provider will do a pregnancy test before they start treatment with Rozlytrek.
Females who are able to become pregnant should use effective birth control during treatment with Rozlytrek and for at least 5 weeks after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rozlytrek and for 3 months after the final dose.
are breastfeeding or plan to breastfeed. It is not known if Rozlytrek passes into breast milk. Do not breastfeed during treatment with Rozlytrek and for 7 days after the final dose of Rozlytrek. Patients should talk to their healthcare provider about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Certain other medicines may affect how Rozlytrek works causing side effects. Patients should know the medicines they take. Patients should keep a list of them to show to their healthcare provider and pharmacist when they get a new medicine.

The most common side effects of Rozlytrek include:

● tiredness

● nausea

● cough

● constipation

● abnormal touch sensation

● vomiting

● change in taste

● shortness of breath

● fever

● swelling

● muscle pain

● joint pain

● dizziness

● confusion, mental status changes, memory problems, and hallucinations

● vision changes

● diarrhea

These are not all the possible side effects of Rozlytrek. For more information, patients should ask their healthcare provider or pharmacist.

Patients should call their doctor for medical advice about side effects.

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

Modra Pharmaceuticals to Present New Phase 2b Data at the 2022 ASCO General Annual Meeting on ModraDoc006/r, a Boosted Oral Taxane for Patients with Metastatic Prostate Cancer

On May 23, 2022 Modra Pharmaceuticals ("Modra") reported that the company will present new data from its Phase 2b trial evaluating ModraDoc006/r, a boosted oral taxane therapeutic versus the standard-of-care IV chemotherapy docetaxel, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) at the upcoming ASCO (Free ASCO Whitepaper) General Annual Meeting held from June 3 – 7, 2022 virtually and in-person in Chicago, IL, USA (Press release, Modra Pharmaceuticals, MAY 23, 2022, View Source [SID1234615952]).

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

                  Schedule Your 30 min Free Demo!

Please see below for details on the poster abstract.

Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Poster Title: A phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Presenter: Ulka N. Vaishampayan, MD | University of Michigan
Location: In-Person & Live Stream | Arie Crown Theater
Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT
Abstract Number: 5016
Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.