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Merck and Eisai Present P-III (LITESPARK-011) Trial Data on Welireg + Lenvima in Advanced Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…

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Roche

Roche Reports P-III (FENhance 1) Trial Data on Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Shots: Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…

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Pfizer, Merck and Astellas Report P-III (KEYNOTE-B15) Trial Findings on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…

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Bayar

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Shots: Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases Trial showed improved OS (2EP), with a 24% reduction in death risk &…

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Pfizer New

Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

Shots: The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…

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Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC

Shots: Partner Therapeutics has reported post-hoc analysis from the eNRGy study assessing zenocutuzumab (marketed as Bizengri in the US) in pts with advanced NRG1+ NSCLC In 27 pts with NRG1+ NSCLC treated with zenocutuzumab (≥3 doses) beyond radiographic progression, 81% had oligoprogression & 19% diffuse progression, extending median exposure to ~10 vs ~7mos. pre-progression. Additionally,…

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