Kyle Doherty

Key Takeaways FDA authorized perioperative pembrolizumab (or pembrolizumab/berahyaluronidase) plus enfortumab vedotin for adult muscle-invasive bladder cancer treated with cystectomy. KEYNOTE-B15/EV-304 showed median event-free survival was not reached with pembrolizumab/enfortumab vedotin versus 48.5 months with gemcitabine/cisplatin. Risk of events was reduced versus chemotherapy (HR, 0.53; 95% CI, 0.41-0.70; P < .0001), supporting a clinically meaningful perioperative benefit. Overall survival data were immature, with median OS not reached in either arm, though favoring pembrolizumab/enfortumab vedotin (HR, 0.65; P = .0029). SHOW MORE

Updated Data From PrTK03 in Prostate Cancer: Key Takeaways Updated phase 3 PrTK03 data showed that aglatimagene besadenovec plus valacyclovir

Key Takeaways Penpulimab achieved a significant DFS benefit versus surveillance (HR 0.37; 95% CI, 0.16–0.89), with higher 1-year (94.25% vs 80.46%) and 2-year DFS (88.68% vs 75.38%). Treatment consisted of penpulimab 200 mg IV every 3 weeks for up to 17 cycles post-nephrectomy in adults with very high-risk ccRCC, ECOG 0–1, and no prior systemic therapy. Prespecified subgroup analyses showed generally consistent DFS improvement across older age, ECOG 0, M0 status, very-high risk T3 disease, and radical nephrectomy cohorts. Safety was manageable: 49.4% had any TRAE, 6.9% had grade 3–4 TRAEs, and common events included rash, proteinuria, pruritus, thyroid dysfunction, and fatigue. Progression correlated with suppressed antitumor immune plasma proteins, depletion of immunostimulatory microbiota-associated metabolites, metabolic reprogramming signatures, and candidate plasma biomarkers linked to relapse risk. SHOW MORE

Laure-Anne Teuwen, MD, PhD, debates the real-world advantages of subcutaneous pembrolizumab.

Targeting PRAME in Melanoma PRAME-directed therapies are showing encouraging activity in heavily pretreated melanoma.

Experts shared the key data that stood out in hematologic oncology at the 2026 ASCO Annual Meeting.

Key Takeaways FDA approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive NSCLC following prior treatment with a ROS1 kinase inhibitor. Phase 1/2 ARROS-1 reported a 44% ORR (95% CI, 34%-53%) in the overall treated population (n = 117). Response durability in ARROS-1 included 6- and 12-month DOR rates of 82% and 69%, respectively. GSK highlighted unmet need and framed the approval as aligned with an asset-acquisition strategy focused on validated targets with potential to shift standards of care. SHOW MORE

Key Takeaways From the FDA Approval of Perioperative Enfortumab Vedotin Plus Pembrolizumab in MIBC

Key Takeaways PACC alterations localize near the EGFR drug-binding pocket and perturb the P-loop/αC-helix, appearing 1.5- to 2-fold more frequently than exon 20 insertions in databases. Compound PACC mutations (e.g., E709X with G719X) are essentially universally phased on the same allele and show reduced first-/third-generation TKI sensitivity in Ba/F3 modeling. Silevertinib 200 mg QD in treatment-naive non-classical EGFR NSCLC achieved 56% ORR in PACC (60% overall), 15.2-month median PFS, and no de novo brain metastases. Firmonertinib in prospective PACC-classified enrollment showed dose-dependent activity, with 240 mg yielding 68.2% ORR and 16.0-month median PFS versus 34.8% ORR at 160 mg. Structure–function annotation is entering molecular reports, differentiating predicted TKI sensitivities for classical-like versus PACC variants and motivating standardized testing plus resistance and microenvironment studies. SHOW MORE

Key Takeaways AI-designed drugs show higher phase 1 success (80%–90%) and similar phase 2 success (~40%) versus historical benchmarks, potentially doubling market-entry probability via faster iteration and QSP integration. Five AI drug-discovery model classes exhibit independent failure modes; concordance across classes can outperform internal confidence, and only target-generation and structure-prediction currently have defensible evidentiary roles. Benchmark design materially changes perceived model utility; TxGemma performed best under drug-blind splits yet worst under cell-blind splits, which better reflects treatment selection for new patients. Multimodal autonomous decision agents achieved 87% accuracy across fictional cases, and CE-marked retrieval-augmented “medical co-pilots” are emerging alongside unresolved interpretability, liability, and regulatory challenges. Cough-based multimodal prescreening models for lung cancer risk/progression show moderate balanced accuracy and variable tradeoffs in sensitivity/specificity, including divergent performance for progression versus pneumonia-related complications. SHOW MORE