Recent developments in oncology highlight advances in targeted therapies and cancer vaccines across multiple tumor types. Fulzerasib has demonstrated efficacy and tolerability in patients with KRAS G12C–mutated metastatic colorectal cancer (CRC), with median overall survival (OS) of 18.2 months and progression-free survival (PFS) of 7.1 months in the mutated cohort. The FDA approved the Oncomine Dx Target Test as a companion diagnostic for zongertinib in nonsquamous non-small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain mutations. Boehringer Ingelheim received FDA approval for Hernexeos, a lung cancer medication showing a 48% objective response rate in patients with HER2-mutated NSCLC previously treated with antibody-drug conjugates. Data from the phase 3 FLAURA2 trial revealed that first-line osimertinib combined with chemotherapy significantly improved OS in patients with EGFR-mutated NSCLC compared to osimertinib alone. In pancreatic and colorectal cancers, a novel cancer vaccine candidate, ELI-002 2P, demonstrated encouraging Phase 1 results by boosting immune response and reducing relapse in patients with residual disease after standard treatment. Similarly, an off-the-shelf vaccine by Elicio Therapeutics showed immune response enhancement in pancreatic cancer patients. Additionally, the ImmunoBody DNA vaccines SCIB1 and iSCIB1+ combined with checkpoint inhibitors produced durable immune responses in advanced unresectable melanoma patients. However, the FDA issued a complete response letter for the biologics license application of vusolimogene oderparepvec plus nivolumab in advanced melanoma patients previously treated with PD-1 inhibitors. Preclinical studies also reported that PF-07248144, a selective inhibitor of KAT6A and KAT6B, can suppress estrogen receptor expression in ER-positive breast cancer. These findings reflect ongoing progress in personalized cancer therapies and immuno-oncology.
Intratumoral vidutolimod as monotherapy or in combination with pembrolizumab in patients with programmed cell death 1 blockade–resistant #melanoma : Final analysis from a phase 1b study https://t.co/NPlPt8csFL This final analysis of a phase 1b, open-label, multicenter study https://t.co/GMNobQZLqs
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On July 22, the @US_FDA issued a CRL to the BLA for vusolimogene oderparepvec plus nivolumab for adults with advanced #Melanoma who have previously received a PD-1 inhibitor. #melsm #FDA Read it all here: https://t.co/HvK2Q4ED3j