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Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Shots:Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III studyAcross all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
October 21, 2025

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Merck Highlights P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Shots:Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643)Trial met its 2EP of improved OS in pts with PD-L1+ tumors, building on previously reported data, which will be presented at ESMO’25;…
October 17, 2025

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HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots:HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…
October 13, 2025

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Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas

Shots:Arcus has reported data from Arm A1 (n=41) of the P-II (EDGE-Gastric) trial assessing domvanalimab (1600mg, IV, Q4W) + Yutuo (480mg, IV, Q4W) & CT in pts with locally advanced unresectable or metastatic G/GEJ or esophageal adenocarcinomaAs of Mar 3, 2025 (mFU of 26.4mos.), pts showed 24mos. OS rate of 50.2% (mOS: 26.7mos.)…
October 13, 2025

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Daiichi Sankyo and AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer

Shots:The global P-III (DESTINY-Breast05) trial data assessed Enhertu (trastuzumab DXd; 5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts with residual invasive disease in breast or axillary lymph nodes after neoadj. therapy & a high risk of recurrenceTrial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…
September 29, 2025

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Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots:The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with AvastinDesignation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
September 16, 2025

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BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025

Shots:BioAtla has shared ongoing P-I dose-escalation trial data on BA3182 for treatment-refractory metastatic adenocarcinoma at ESMO 2025As of June 20, 2025, 39 pts received BA3182 (QW) in the range of 0.0026 to 0.6mg with either 0, 1, or 2 priming doses, 4–7 days before treatment; 17 received IV doses (0.0026–0.032mg) & 22 received SC doses…
July 7, 2025

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