June 18, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Approves Merck’s KEYTRUDA, Junshi's sNDA for Toripalimab, Evaxion's 67% Response Rate

  1. FDA approves Merck’s Keytruda plus carboplatin and paclitaxel for advanced or recurrent endometrial carcinoma
    • The FDA has approved Keytruda in combination with carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial carcinoma.
    • This approval is based on data from the Phase 3 NRG-GY018 trial, which showed a significant reduction in disease progression or death.
    • Keytruda plus carboplatin and paclitaxel reduced the risk of disease progression or death by 40% in pMMR patients and by 70% in dMMR patients.
    • The trial enrolled 810 patients and included two separate cohorts based on MMR status.
    • The approval was reviewed under Project Orbis, and the application is still under review by health authorities in several countries.
    • Next steps include ongoing reviews by health authorities in Israel, Canada, Australia, Singapore, Brazil, and the United Kingdom.
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  2. Junshi Biosciences announces approval of the sNDA for toripalimab for the 1st-line treatment of small cell lung cancer
    • The National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
    • The approval is based on data from the EXTENTORCH study (NCT04012606), a Phase 3 clinical trial comparing toripalimab with placebo in combination with chemotherapy.
    • The EXTENTORCH study met its primary endpoints of overall survival (OS) and progression-free survival (PFS), making toripalimab the first PD-1 inhibitor to achieve these results in a Phase 3 study for ES-SCLC.
    • Study results showed that toripalimab significantly prolonged PFS and OS compared to chemotherapy alone, with a median PFS of 5.8 months and a median OS of 14.6 months.
    • Toripalimab demonstrated a favorable safety profile and reduced the risk of disease progression or death by 33.3% and the risk of death by 20.2%.
    • The approval provides a new, effective, and safe treatment option for SCLC patients in China.
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  3. Evaxion publishes data showing 67% objective response rate in metastatic melanoma for the AI-designed personalized cancer vaccine EVX-01
    • Evaxion's Phase 1 study of EVX-01 shows a 67% objective response rate (ORR) in metastatic melanoma patients.
    • The study, published in the Journal for ImmunoTherapy of Cancer, included 12 patients with 6 partial and 2 complete responses.
    • EVX-01 did not induce vaccine-related serious adverse events when co-administered with anti-PD1 therapy.
    • The vaccine targets neoantigens, making it personalized to each patient's tumor and immune system profile.
    • Phase 2 study data presented at ASCO showed 71% of administered neoantigens induced a specific T-cell response.
    • One-year clinical efficacy readout from the Phase 2 study is expected in Q3 2024.
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  4. Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
    • Johnson & Johnson has submitted a Biologics License Application (BLA) to the U.S. FDA for subcutaneous (SC) amivantamab for EGFR-mutated non-small cell lung cancer (NSCLC).
    • The application is based on Phase 3 PALOMA-3 study results, which showed a five-fold reduction in infusion-related reactions and comparable overall response rates to intravenous (IV) administration.
    • SC amivantamab demonstrated longer overall survival, progression-free survival, and duration of response compared to IV administration.
    • The BLA submission includes data from the Phase 2 PALOMA-2 study, supporting dosing schedules of every two and every three weeks.
    • The subcutaneous option could significantly improve the treatment experience for patients, oncologists, and nursing staff.
    • Next steps include working with the FDA and global regulators for the review of these applications.
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  5. Mustang Bio announces favorable efficacy and safety data from complete Waldenstrom macroglobulinemia cohort of phase 1/2 clinical trial of MB-106, CD20-targeted autologous CAR-T therapy
    • Overall response rate of 90% in the cohort with durable responses observed.
    • One patient remains in complete remission at 31 months.
    • All patients were heavily pretreated/refractory to BTK inhibitors.
    • Outpatient administration was allowed and found to be feasible.
    • No FDA-approved CAR-T treatments currently exist for WM.
    • Data presented at the European Hematology Association 2024 Hybrid Congress.
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  6. iTeos and GSK initiate GALAXIES Lung-301 phase 3 study for belrestotug and dostarlimab in NSCLC
    • iTeos Therapeutics and GSK have started the global Phase 3 GALAXIES Lung-301 study.
    • The study will assess belrestotug and dostarlimab in previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC).
    • The trial is randomized, double-blind, placebo-controlled, and multicenter, enrolling approximately 1,000 patients across North America, South America, Europe, and Asia.
    • Primary endpoints are progression-free survival and overall survival.
    • An interim assessment from the Phase 2 GALAXIES Lung-201 study showed the belrestotug + dostarlimab doublet exceeded pre-defined efficacy criteria and had an acceptable safety profile.
    • Patients will be randomized 1:1 to receive either the belrestotug + dostarlimab doublet or placebo + pembrolizumab.
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  7. SELLAS Life Sciences announces positive recommendation from the independent data monitoring committee of the Phase 3 REGAL trial in acute myeloid leukemia
    • The Independent Data Monitoring Committee (IDMC) recommends continuation of the Phase 3 REGAL trial without any modifications.
    • No safety or futility concerns were raised based on the efficacy and safety assessment of all REGAL patients.
    • Interim analysis is anticipated by Q4 2024.
    • REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy.
    • The primary endpoint of the trial is overall survival.
    • The IDMC is responsible for periodic reviews of safety, efficacy, and futility, in addition to interim and final analyses.
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  8. EUROAPI and Priothera enter into CDMO collaboration to advance oncology project
    • EUROAPI and Priothera have signed a 5-year CDMO agreement to develop and industrialize mocravimod.
    • Mocravimod is an innovative molecule for the treatment of blood cancers, currently in a global phase 3 trial.
    • The project will be carried out at EUROAPI’s Budapest site, a center of excellence for complex chemistry.
    • The phase 3 trial is enrolling approximately 250 adult Acute Myeloid Leukemia patients across the US, Europe, Asia, and Latin America.
    • Mocravimod has been granted Orphan Drug designation by both EMA and US FDA.
    • Priothera aims for worldwide drug registration and commercialization of mocravimod by 2027.
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  9. Precision-Panc team opens the PRIMUS-006 study, a novel combination of IMM-101, gemcitabine and pembrolizumab
    • The Phase II PRIMUS-006 study is evaluating IMM-101, gemcitabine, and pembrolizumab as first-line treatment for metastatic pancreatic cancer.
    • The study is part of the Precision-Panc Platform master protocol program, co-sponsored by NHS Greater Glasgow & Clyde and the University of Glasgow.
    • Funded by Merck Sharp & Dohme LLC and Immodulon Therapeutics Ltd, the study aims to enhance anti-tumor activity in pancreatic cancer.
    • The primary endpoint is the objective response rate as defined by RECIST 1.1, with secondary endpoints including safety, tolerability, progression-free survival, disease control rate, and overall survival.
    • Up to 50 patients will be treated across 15-20 hospital sites in the UK.
    • IMM-101 is a broad-spectrum immunomodulator with potential to treat immunologically 'cold' cancers like pancreatic cancer.
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  10. Northwest Biotherapeutics announces exclusive in-license of portfolio of dendritic cell technology and intellectual property
    • Northwest Biotherapeutics (NW Bio) has secured an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property.
    • The licensed technologies are already in Phase 2 clinical trials, with plans to collaborate with Dr. Pawel Kalinski for further development.
    • The license includes 5 new patent families filed in 2023, covering enhanced dendritic cells (DCs) and DC-based therapies.
    • Phase 2 trials for two different cancers are currently underway, with a third trial pending. These trials are fully funded by grants and are investigator-led.
    • The terms of the license include an upfront fee and milestone payments totaling approximately $2.3 million, along with royalties on product sales.
    • NW Bio aims to leverage its experience in personalized cell therapy to accelerate the development of the licensed DC technologies.
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