Daily Roundup | BioNTech/DualityBio Breast ADC Gain Called Modest & Merck's sac-TMT Survival Edge Under FDA Review

October 26, 2026 edition, released October 27. Recorded October 26: references to today mean October 26, and tomorrow means October 27.

BioNTech and DualityBio's breast cancer ADC beat chemo in Phase 3, yet the companies call the gain modest. Merck and Kelun's sac-TMT showed interim median overall survival of 19.0 vs 12.1 months in endometrial cancer after platinum and immunotherapy and is under FDA priority review. Also: Keytruda (pembrolizumab) alone in first-line dMMR endometrial cancer; FDA approval of Talzenna (talazoparib) plus Xtandi (enzalutamide) for adults with metastatic, androgen pathway modulation-naive or -sensitive prostate cancer with HRR mutations detected by an FDA-authorized test; BMS/SystImmune's iza-bren in EGFR-mutated lung cancer; GSK/Hansoh's ris-rez in osteosarcoma; and Corxel US/Amanat's proposed deal that would help fund oral GLP-1 CX11.

Sources:
- SEC (BioNTech Exhibit 99.1): DYNASTY-Breast02 topline Phase 3 results for trastuzumab pamirtecan — October 26, 2026 — https://www.sec.gov/Archives/edgar/data/0001776985/000177698526000074/a991261025_bntxdbxtpamxtop.htm
- FDA: Approval of fam-trastuzumab deruxtecan-nxki in HR-positive HER2-low or HER2-ultralow metastatic breast cancer — January 2025 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2
- Merck: TroFuse-005 sacituzumab tirumotecan endometrial results and FDA priority review — October 26, 2026 — https://www.merck.com/news/sacituzumab-tirumotecan-sac-tmt-reduced-the-risk-of-death-by-32-and-the-risk-of-disease-progression-or-death-by-41-compared-to-chemotherapy-in-certain-patients-with-advanced-or-recurrent-endometrial/
- Merck: KEYNOTE-C93 Keytruda monotherapy in dMMR endometrial cancer — October 26, 2026 — https://www.merck.com/news/keytruda-pembrolizumab-as-monotherapy-reduced-the-risk-of-disease-progression-or-death-by-43-for-certain-patients-with-advanced-or-recurrent-endometrial-cancer-with-mismatch-repair-deficient/
- FDA: Approval of talazoparib with enzalutamide in metastatic androgen pathway modulation-naive or -sensitive prostate cancer — October 26, 2026 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-talazoparib-enzalutamide-metastatic-androgen-pathway-modulation-naive-or-sensitive
- Bristol Myers Squibb: PANKU-Lung01 Phase 3 results for izalontamab brengitecan — October 26, 2026 — https://news.bms.com/news/corporate-financial/2026/Izalontamab-Brengitecan-Iza-Bren-Doubles-Median-Progression-Free-Survival-in-Patients-with-Previously-Treated-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-Compared-to-Chemotherapy-in-the-Phase-3-PANKU-Lung01-Study/default.aspx
- FDA: Approval of amivantamab-vmjw with carboplatin and pemetrexed after EGFR TKI — September 19, 2024 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19
- GSK: ARTEMIS-011 ris-rez in relapsed osteosarcoma in China — October 26, 2026 — https://www.gsk.com/en-gb/media/press-releases/ris-rez-reduced-risk-of-disease-progression-or-death-by-67-versus-chemotherapy-in-patients-with-relapsed-osteosarcoma-in-china/
- SEC (Exhibit 99.1): Corxel and Amanat proposed business combination and financing — October 26, 2026 — https://www.sec.gov/Archives/edgar/data/2112457/000121390026112236/ea030895401ex99-1.htm
- FDA: Approval of talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer — June 20, 2023 — https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate