Regeneron announced that FDA has accepted for review the resubmission of BLA for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025.
Odronextamab BLA accepted for FDA review for the treatment of follicular lymphoma
Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL (OLYMPIA -1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response. Serious adverse events occurred in 67% of patients; those occurring in ≥10% of patients included cytokine release syndrome, COVID-19 and pneumonia. Odronextamab is approved as Ordspono™ in the European Union for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy although its safety and efficacy have not been fully evaluated by any other regulatory authority.
Keytruda and Lenvima combo missed OS mark in HER2- gastroesophageal cancer
Merck & Co and Eisai announced results from the Phase 3 LEAP-015 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor TKI discovered by Eisai, in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastroesophageal adenocarcinoma. At an interim analysis, the Keytruda plus Lenvima-based regimen demonstrated a statistically significant improvement in PFS, one of the study’s dual primary endpoints, and ORR, a key secondary endpoint, compared to standard of care chemotherapy. The study continued, and at the final analysis, it did not meet its other primary endpoint of OS. The safety profile of the Keytruda plus Lenvima-based regimen was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing, and Merck and Eisai will present these results at an upcoming medical meeting.
AdvanCell raised $112 million and entered will work with Lilly to advance novel targeted alpha therapies
AdvanCell, a clinical-stage radiopharmaceutical company specializing in targeted alpha therapies, vanCell, announced the successful completion of an oversubscribed $112 million Series C financing. This milestone funding round was co-led by SV Health Investors, Sanofi Ventures, Abingworth and SymBiosis. Additional support came from existing investor Morningside, alongside new investors Tenmile, Brandon Capital, and others. This investment will fuel AdvanCell’s ongoing efforts to expand its manufacturing capacity, accelerate the clinical development of its pipeline of radionuclide therapies, and advance its mission of delivering life-changing treatments to cancer patients worldwide. AdvanCell separately announced an expansion to the scope and breadth of its strategic collaboration with Eli Lilly and Company to research and develop innovative treatments for various cancers. Under this new agreement, the parties will leverage AdvanCell’s proprietary Pb-212 production technology and radionuclide development infrastructure and Lilly’s drug candidate programs and extensive expertise in drug development to facilitate the development and accelerate the clinical advancement of an expanded portfolio of targeted alpha therapies. AdvanCell’s competitive advantage in technology development and the infrastructure it has built to accelerate early-stage clinical trials in Australia enables AdvanCell to rapidly develop and progress novel Pb-212-containing radiotherapeutics from discovery into clinical trials. Financial terms of the agreement were not disclosed.
