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What’s in Today’s Brief? (April 13th Preview)
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Pancreatic cancer survival jump in Phase 3
Revolution Medicines said daraxonrasib, its KRAS-targeted drug for metastatic pancreatic cancer, met early goals in a Phase 3 checkpoint and the company ended the study early after survival benefits at an interim analysis. In the RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy, a 60% relative risk reduction at the interim look. Revolution’s results were reported for a registrational setting in patients whose metastatic disease had returned after prior treatment. The FDA has already granted daraxonrasib a national priority voucher, which could compress the approval timeline after a submission. Revolution plans to present additional trial details at an upcoming American Society of Clinical Oncology meeting, and investors focused on whether the strongest benefit was driven by the RAS G12-mutated subgroup.
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Allogene’s off-the-shelf CAR-T posts MRD results in lymphoma
Allogene Therapeutics reported early clinical data showing its cema-cel “off-the-shelf” CAR-T therapy eliminated detectable lymphoma cells at rates exceeding standard care in an interim readout of an ongoing Phase 3 trial. In the company’s interim analysis, 58% of patients receiving cema-cel achieved minimal residual disease (MRD) negativity versus 16% in an observational control arm. The company previously emphasized MRD as a validated milestone linked in the literature to delaying relapse. Allogene is positioning the approach as a more convenient alternative to personalized CAR-T, and the preliminary safety signal included predominantly low-grade neurological events in earlier slices of data. Full registrational conclusions are still pending as the Phase 3 study continues.
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FDA filing path for BioNTech’s HER2 ADC
BioNTech disclosed positive Phase 2 results for trastuzumab pamirtecan (BNT323), setting the stage for an FDA filing as the company looks to compete in HER2-positive oncology where antibody-drug conjugates are gaining share. The company said the Phase 2 readout supports further development in defined patient populations, with additional regulatory steps planned following the data. BioNTech framed the program as a potential alternative to existing HER2 ADC options in subgroups where prior therapies may be limited. The announcement comes as multiple HER2 ADCs vie for space in breast and gastric cancer treatment algorithms, making population-level efficacy and safety details central to how regulators and clinicians interpret the next filing package.
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GSK expands gynecologic cancer ADC trials after early data
GSK said it plans to start five Phase 3 studies for a gynecological cancer antibody-drug conjugate licensed from Hansoh Pharma after early promising data. The company’s decision expands the trial footprint for the asset into a broader late-stage program, reflecting how ADC developers are moving quickly from early efficacy into registrational strategies across multiple tumor settings. The update also underscores the competitive intensity in women’s cancers, where ADC platforms are being tested not only for efficacy but for how consistent they perform across histologies and lines of therapy.
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Oncology ADC financing boosts next-gen targeting
Sidewinder Therapeutics raised $137 million in a Series B to advance a pipeline of bispecific antibody-drug conjugates aimed at improving tumor targeting and safety. The round was co-led by Frazier Life Sciences and Novartis Venture Fund, with OrbiMed returning alongside new investors. Sidewinder said it uses Lonza’s Synaffix site-specific linker-payload and has signed a multi-target licensing agreement with Lonza to help refine the therapeutic index. The company’s lead program, SWT012, is targeting an IND filing with the FDA by the end of 2026 and planned clinical initiation in 2027, with two additional oncology programs on a similar timeline. The financing highlights investor appetite for next-generation ADC formats that can manage efficacy tradeoffs seen in earlier generations.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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