August 8, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Merck's KeyVibe-008, Citius FDA Approval, WestGene's Dual INDs

1. Merck discontinues phase 3 KeyVibe-008 trial for extensive-stage small cell lung cancer

   • Merck has halted the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC).
   • The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab with chemotherapy versus atezolizumab with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
   • The primary endpoint of overall survival (OS) met the pre-specified futility criteria, and the combination arm showed higher rates of adverse events (AEs) and immune-related AEs.
   • Merck is notifying study investigators and offering patients the option to switch to atezolizumab treatment.
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2. Invenra highlights Exelixis’ announcement: initiation of phase 1 clinical trial evaluating XB010 in patients with advanced solid tumors

   • Exelixis has initiated the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010.
   • XB010 is an antibody-drug conjugate (ADC) targeting the tumor antigen 5T4, constructed using Catalent’s SMARTag platform.
   • The trial will evaluate XB010 as a single agent and in combination with pembrolizumab.
   • Expansion cohorts will further assess the tolerability and activity of monotherapy and combination therapy in specific indications.
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3. WestGene to advance clinical trials following dual IND approvals for world's first EB virus-related mRNA therapeutic cancer vaccine

   • WestGene Biopharma's mRNA therapeutic cancer vaccine, WGc-043, received dual IND approvals from China's NMPA and the US FDA.
   • The approvals allow the initiation of Phase I clinical trials for WGc-043, targeting EBV-related cancers.
   • WGc-043 uses AI-assisted antigen screening and an advanced LNP delivery system to enhance anti-tumor immunity.
   • The vaccine has shown superior safety and efficacy in investigator-initiated trials for nasopharyngeal carcinoma and natural killer T-cell lymphoma.
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4. Le traitement d’induction par Sarclisa améliore la survie sans progression chez les patients atteints de myélome multiple

   • Sarclisa (isatuximab) combiné avec lénalidomide, bortézomib et dexaméthasone (RVd) a montré une amélioration significative de la survie sans progression (PFS) chez les patients nouvellement diagnostiqués et éligibles à une greffe.
   • L'étude GMMG-HD7, une phase 3 randomisée, a démontré une réduction statistiquement et cliniquement significative de la progression de la maladie ou de la mort par rapport à l'induction RVd seule.
   • Les résultats complets seront présentés lors d'une prochaine réunion médicale.
   • Sarclisa continue d'être évalué dans plusieurs études cliniques de phase 3 pour diverses populations de patients atteints de myélome multiple.
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5. Citius Pharmaceuticals receives FDA approval for Lymphir immunotherapy for relapsed or refractory cutaneous T-cell lymphoma

   • Lymphir is the only systemic treatment for relapsed or refractory CTCL targeting the IL-2 receptor on malignant T-cells and Tregs.
   • Approval based on Phase 3 Pivotal Study 302 results showing a 36% ORR, 84% reduction in skin disease, and significant pruritis improvement.
   • Lymphir is expected to launch in the U.S. market within the next five months.
   • Postmarketing requirement includes characterizing the risk of visual impairment in CTCL patients treated with Lymphir.
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6. Agenus publishes seminal study on botensilimab’s activity in treatment-resistant cancers

   • Botensilimab, an investigational anti-CTLA-4 antibody, shows increased activity in multiple treatment-resistant cancers.
   • The Fc-enhanced design of botensilimab allows for multifunctional immune activation, enhancing T cell priming and reducing intratumoral regulatory T cells.
   • Botensilimab demonstrates clinical activity independent of conventional limitations, broadening its potential applicability.
   • The antibody remodels the tumor microenvironment, transforming 'cold' tumors into 'hot' immunologically active tumors.
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7. Immunocore reports second quarter financial results and provides a business update

   • KIMMTRAK net revenues reached $75.3 million in Q2 2024, driven by US growth.
   • Ongoing Phase 3 TEBE-AM trial for KIMMTRAK in previously treated cutaneous melanoma, with enrollment expected to complete in 1H 2026.
   • Phase 3 PRISM-MEL-301 trial evaluating brenetafusp + nivolumab in first-line cutaneous melanoma has started randomization.
   • Presented Phase 1 data of brenetafusp in late-line cutaneous melanoma at ASCO 2024; ovarian cancer data to be presented at ESMO 2024.
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8. Aura Biosciences reports second quarter 2024 financial results and business highlights

   • Aura Biosciences reported financial results for Q2 2024, with a net loss of $20.3 million.
   • The company will present early NMIBC data from an ongoing Phase 1 trial at a urologic oncology event in October 2024.
   • Phase 2 end of study data for bel-sar in early-stage choroidal melanoma will be presented at the Retina Society Annual Meeting in September 2024.
   • Aura's strong cash position is expected to fund operations into the second half of 2026.
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9. Monte Rosa Therapeutics announces second quarter 2024 financial results and provides corporate update

   • IND clearance achieved for MRT-6160, a VAV1-directed MGD for autoimmune diseases; Phase 1 SAD/MAD study to start this summer with initial data expected in Q1 2025.
   • Ongoing Phase 1/2 study of MRT-2359 for MYC-driven solid tumors shows favorable safety at 0.5 mg; dosing ongoing at 0.75 mg with Phase 2 dose and updated results expected in H2 2024.
   • Achieved first program and financial milestones from strategic research collaboration with Roche.
   • Strong cash position expected to fund operations into H1 2027, supporting multiple clinical readouts including MRT-2359, MRT-6160, and MRT-8102.
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10. Cullinan Therapeutics provides corporate update and reports second quarter 2024 financial results

    • IND application for CLN-978 in systemic lupus erythematosus (SLE) on track for Q3 2024.
    • Plans to explore CLN-978 in rheumatoid arthritis (RA) with clinical trials in collaboration with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore.
    • Presented CLN-619 combination therapy data at ASCO showing objective responses in NSCLC.
    • Completed $280 million private placement and appointed Mary Thistle to the Board of Directors.
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