On September 3, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, SEP 3, 2024, View Source [SID1234646328]). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC.

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Prostate cancer is one of the most common cancers in men.1 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,2 occurring in approximately 11% of diagnoses.3 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.4

"This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Our high-quality tissue and liquid biopsy companion diagnostic tests will allow more patients to access genomic testing, regardless of specimen type, and will simplify complex decisions by generating the best information to enable better decision-making. There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. From a simple blood sample, FoundationOneLiquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With today’s approval, Foundation Medicine is the only company that has seven FDA-approved companion diagnostic indications for prostate cancer.5 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.6

"This is an important milestone for men with aggressive prostate cancer," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications."

Lynparza is jointly developed and commercialized by AstraZeneca and Merck.

On September 3, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, reported that it will provide an overview of the Company at 3:00 p.m. EDT on Monday, September 9 at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Puma Biotechnology, SEP 3, 2024, View Source [SID1234646327]). The conference will be held September 9 – 11, 2024 at the Lotte New York Palace Hotel in New York City.

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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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A live webcast of the presentation will be available on the Company’s website at View Source The presentation will be archived on the website and available for 30 days.

On September 3, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that Steven Kelly, President and Chief Executive Officer, will participate in the following upcoming conferences (Press release, Carisma Therapeutics, SEP 3, 2024, View Source [SID1234646326]):

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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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Baird 2024 Global Healthcare Conference

Tuesday, September 10 at 12:50 PM ET
New York, NY

H.C. Wainwright 26th Annual Global Investment Conference

Wednesday, September 11 at 1:30 PM ET
New York, NY

Chardan’s 8th Annual Genetic Medicines Conference

Monday, September 30 at 4:00 PM ET
New York, NY

The Cell & Gene Meeting on the Mesa

Monday, October 7 at 9:30 AM MST
Phoenix, AZ
Live webcasts will be available on the Company’s Investor Events webpage. A replay of the webcasts, when available, will be archived for a limited time following the event.

On September 3, 2024 AVEO Oncology, an LG Chem company ("AVEO"), reported their late-breaking abstract detailing their Phase 3 TiNivo-2 trial has been selected as a Proffered Paper oral presentation at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain this September 13-17th (Press release, AVEO, SEP 3, 2024, View Source [SID1234646325]).

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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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The oral presentation will announce the results from the TiNivo-2 clinical trial, which was designed to evaluate the benefit of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose (0.89mg) FOTIVDA (tivozanib), a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) versus standard dose (1.34mg) FOTIVDA in the second-line following immune checkpoint inhibitor (ICI) combinations or the third-line setting following prior ICI treatment. Details of the presentation are as follows:

Title:

Tivozanib Plus Nivolumab vs Tivozanib Monotherapy in Patients With
Metastatic Renal Cell Carcinoma Following an Immune Checkpoint
Inhibitor: Results of the Phase 3 TiNivo-2 Study

Speaker:

Toni Choueiri, MD, Director of the Lank Center for Genitourinary (GU)
Oncology at Dana-Farber Cancer Institute, Boston, MA, United States of America

Presentation #:

LBA73

Category:

Proffered Paper session 1: GU tumors, non-prostate

Date & Time:

Friday, September 13, 2024; 2:00 – 2:10 pm CET

TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors progressed following prior ICI therapy.

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation VEGFR TKI. It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

On September 3, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported that Lunit SCOPE IO has demonstrated significant potential in predicting immunotherapy response for patients with advanced biliary tract cancer (BTC), via AI-powered analysis of immune phenotype and tumor-infiltrating lymphocytes (TILs) (Press release, Lunit, SEP 3, 2024, View Source;new-publication-in-ccr-302236317.html [SID1234646324]). The groundbreaking study, conducted in collaboration with researchers from Asan Medical Center and Severance Hospital in Seoul, Korea, was recently published in Clinical Cancer Research (CCR), an AACR (Free AACR Whitepaper) journal.

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BTC is known for its poor prognosis, with limited treatment options available. While recent studies have shown promise in combining immunotherapy, such as anti-PD-1 inhibitors with standard chemotherapy, there has been a lack of effective predictive tools to guide treatment decisions.

The study analyzed pre-treatment pathology samples (H&E slides) from 339 patients with advanced BTC who received anti-PD-1 monotherapy as second-line or later treatment. Using Lunit SCOPE IO, researchers performed a detailed analysis of the tumor microenvironment, classifying patients’ immune phenotypes into three categories: inflamed (high intratumoral TIL), immune-excluded (low intratumoral TIL and high stromal TIL), and immune desert (low TIL overall). Immune phenotypes are an emerging pan-cancer biomarker with support from leaders of the immuno-oncology community.[1]

Key findings include:

Patients classified as having an "inflamed" immune phenotype showed significantly better treatment outcomes compared to those with non-inflamed phenotypes, as consistent with previously published studies.[2]
The inflamed group demonstrated both longer overall survival (12.6 vs. 5.1 months) and progression-free survival (4.5 vs. 1.9 months), as well as higher overall response rates (27.5% vs. 7.7%).
Lunit SCOPE IO provided objective and efficient assessment of the tumor microenvironment, overcoming limitations of manual evaluation demonstrating high feasibility for AI-powered analysis of immune phenotype and TIL.
Notably, this study suggests immune phenotyping can serve as a predictive biomarker for possible response to immunotherapy in BTC, addressing a long-standing gap in personalized treatment approaches for this class of cancers with a high unmet need.

"Lunit SCOPE IO represents a significant advancement in the precision medicine landscape for cancer treatment," said Brandon Suh, CEO at Lunit. "By providing a deeper understanding of the tumor microenvironment, particularly immune phenotyping, our AI technology empowers clinicians to make informed treatment decisions, identifying patients most likely to benefit from immunotherapy and opening new avenues for personalized treatment strategies in challenging cancer types."