June 24, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Approvals, Clinical Updates & More

  1. Bristol Myers Squibb announces U.S. FDA accelerated approval of KRAZATI (adagrasib) in combination with cetuximab for adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC)
    • The U.S. FDA has granted accelerated approval for KRAZATI (adagrasib) in combination with cetuximab for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
    • Approval is based on objective response rate (ORR) and duration of response (DOR) results from the Phase 1/2 KRYSTAL-1 study.
    • The study showed a confirmed ORR of 34% and a median DOR of 5.8 months in 94 patients with heavily pretreated CRC.
    • KRAZATI is associated with gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease (ILD)/pneumonitis.
    • Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
    • Bristol Myers Squibb partnered with QIAGEN to develop a tissue-based companion diagnostic (CDx) for KRAZATI.
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  2. Takeda receives approval from European Commission for fruzaqla in previously treated metastatic colorectal cancer
    • The European Commission (EC) approved FRUZAQLA (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with standard therapies.
    • The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and prior approval by the U.S. FDA.
    • The decision is based on results from the Phase 3 multi-regional FRESCO-2 trial, which met all primary and key secondary efficacy endpoints.
    • FRUZAQLA demonstrated a manageable safety profile, with adverse reactions leading to treatment discontinuation in 20% of patients.
    • Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau.
    • A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023.
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  3. BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
    • The FDA granted Fast Track designation for BNT324/DB-1311 for advanced or metastatic castration-resistant prostate cancer (CRPC).
    • Designation is based on pre-clinical data and ongoing Phase 1/2 trial results showing antitumor activity and a manageable safety profile.
    • Fast Track designation allows for more frequent engagement with the FDA to expedite development and regulatory review.
    • Prostate cancer is the second leading cause of cancer-related deaths among men worldwide, with a 5-year survival rate of around 36% for metastatic CRPC.
    • BNT324/DB-1311 targets the B7-H3 protein, which is overexpressed in various tumors and associated with poor prognosis.
    • This is the third ADC candidate in BioNTech and DualityBio’s collaboration to receive FDA Fast Track designation.
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  4. HUTCHMED announces European Commission approval for fruzaqla (fruquintinib) received by Takeda
    • The European Commission (EC) has approved FRUZAQLA (fruquintinib) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with standard therapies.
    • Approval is based on positive results from the Phase III FRESCO-2 trial, which demonstrated significant improvement in overall survival and progression-free survival.
    • FRUZAQLA is the first novel targeted therapy for metastatic CRC in the EU in over a decade, regardless of biomarker status.
    • The FRESCO-2 trial was a multiregional study conducted in the U.S., Europe, Japan, and Australia, showing consistent benefits across different patient groups.
    • Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau.
    • Submissions for regulatory approval in Japan are ongoing, with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) submission made in September 2023.
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  5. Adicet Bio announces FDA clearance of IND application for ADI-270 in renal cell carcinoma
    • Adicet Bio received FDA clearance for its IND application to evaluate ADI-270 in relapsed/refractory renal cell carcinoma (RCC).
    • ADI-270 is an armored allogeneic gamma delta CAR T cell therapy targeting CD70+ cancers.
    • The Phase 1 clinical trial will start in the second half of 2024, assessing safety and anti-tumor activity.
    • The trial will be a multicenter, open-label study involving adults with relapsed or refractory clear cell RCC.
    • Patients will receive a single dose of ADI-270, with potential eligibility for a second dose based on protocol criteria.
    • The trial will evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity, including overall response rate and disease control rate.
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  6. IDEAYA Biosciences announces clinical program updates for IDE397, a potential first-in-class phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors
    • IDEAYA targets a clinical data update for IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion bladder and lung cancer in H2 2024.
    • The update will include clinical efficacy summaries, adverse event profiles, pharmacokinetics, and pharmacodynamics.
    • Initiating IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder cancer, alongside the existing expansion in MTAP-deletion squamous lung cancer.
    • Activated over 35 clinical trial sites globally to enable rapid enrollment for the IDE397 Phase 2 program.
    • Ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors and a Phase 1/2 trial of IDE397 and AMG 193 combination in MTAP-deletion NSCLC.
    • Advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397.
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  7. Starton Therapeutics announces 100% partial response or better in multiple myeloma patients in interim, top-line data from STAR-LLD Phase 1b clinical trial
    • 100% of patients achieved a partial response or better within 1-3 cycles.
    • Milder and less frequent drug-related adverse events compared to Revlimid.
    • No grade 3 or greater adverse events in neutropenia, thrombocytopenia, or diarrhea.
    • Phase 2 studies in multiple myeloma and chronic lymphocytic leukemia planned for 2025.
    • The company will prepare a summary of data on safety and activity for the FDA.
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  8. OSE Immunotherapeutics announces commercial and revenue sharing agreement in the field of CAR T-cell therapies
    • OSE Immunotherapeutics has entered into a commercial and revenue sharing agreement with Memorial Sloan Kettering Cancer Center (MSK).
    • The agreement covers OSE's patent rights and jointly owned OSE/MSK patent rights in CAR cell therapy for IL-7R expressing cancers, particularly hematological tumors like Acute Lymphoblastic Leukemia.
    • MSK will lead the research, development, and commercialization efforts, sharing potential future revenues with OSE Immunotherapeutics.
    • The agreement builds on an initial multi-year research collaboration exploring a non-antagonist IL-7R monoclonal antibody for cancer indications.
    • This collaboration aims to develop innovative CAR-T cells targeting IL-7R expressing cancers.
    • Next steps include clinical trials at MSK to explore the therapeutic potential of IL-7R targeted CARs.
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