Merck’s sac-TMT cut the risk of death 32% in previously treated endometrial cancer at ESMO on October 26, 2026, and the FDA set its decision for June 15, 2027.
Last updated: October 27, 2026
In the Phase 3 TroFuse-005 trial, sacituzumab tirumotecan extended median overall survival to 19.0 months versus 12.1 months for chemotherapy in previously treated endometrial cancer, a 32% reduction in the risk of death. The FDA accepted Merck’s BLA with priority review and a June 15, 2027 action date.
This page covers the TroFuse-005 data and regulatory timeline, the market’s first reaction to the ESMO 2026 weekend, the iza-bren and KRAS G12D readouts, Anthropic’s IPO filing, Windward Bio’s F-1, and the Gilead and Roche deals from late last week.
How much did sac-TMT improve survival in endometrial cancer?
Sacituzumab tirumotecan reduced the risk of death 32% versus chemotherapy (hazard ratio 0.68) in TroFuse-005, with median overall survival of 19.0 versus 12.1 months, median progression free survival of 7.2 versus 3.9 months, and a 35.1% versus 17.3% response rate, per Merck’s October 26 release.
TroFuse-005 (NCT06132958) is a randomized, active controlled, open label, global Phase 3 study of 776 patients with advanced or recurrent endometrial carcinoma previously treated with platinum based chemotherapy and a PD-1 or PD-L1 inhibitor. Patients received sac-TMT at 4 mg/kg every two weeks or treatment of physician’s choice: doxorubicin or paclitaxel. The results below come from a pre specified interim analysis at a median follow up of 14.0 months, were presented Monday as a late breaker (LBA11) in Presidential Symposium III at the ESMO Congress 2026 in Madrid, and were published simultaneously in The Lancet. Merck describes TroFuse-005 as the first Phase 3 trial of a TROP2 directed antibody drug conjugate in this population.
| TroFuse-005 interim analysis | sac-TMT | Physician’s choice chemotherapy |
|---|---|---|
| Median overall survival (dual primary) | 19.0 months | 12.1 months |
| Overall survival hazard ratio | 0.68 (95% CI 0.55 to 0.84; P<0.0001) | |
| Median progression free survival (dual primary, BICR) | 7.2 months | 3.9 months |
| Progression free survival hazard ratio | 0.59 (95% CI 0.50 to 0.70; P<0.0001) | |
| Objective response rate | 35.1% | 17.3% |
| Complete responses | 6.1% | 4.5% |
| Median duration of response | 11.1 months | 6.9 months |
Sacituzumab tirumotecan is a TROP2 directed antibody drug conjugate that Merck licensed from Sichuan based Kelun. Merck says it is evaluating the molecule in 18 ongoing global Phase 3 trials, which makes TroFuse-005 the first survival verdict on the asset most analysts treat as the lead successor to Keytruda, whose US exclusivity begins eroding in 2028.
When will the FDA decide on sac-TMT in endometrial cancer?
The FDA accepted Merck’s Biologics License Application for sac-TMT with priority review and set a Prescription Drug User Fee Act target action date of June 15, 2027. Merck said it is hopeful for an approval before that date, based on its discussions with the agency.
The requested indication covers adults with endometrial cancer previously treated with platinum containing chemotherapy and a PD-1 or PD-L1 inhibitor, given separately or together. Merck also plans to discuss the data with other global regulators. The FDA has repeatedly acted ahead of its stated dates in 2026, from Fayuvi at two days early to Anktiva’s papillary indication at nearly three months, so an approval well before June 2027 would fit the agency’s recent pattern. This is the first US filing for sac-TMT in any indication.
How safe was sac-TMT in TroFuse-005?
Grade 3 or higher treatment related adverse events occurred in 54.4% of sac-TMT patients versus 41.4% on chemotherapy, led by anemia (23.7%), neutropenia (20.1%), and stomatitis (9.9%). Discontinuations for treatment related events were lower on sac-TMT, at 3.1% versus 4.9%.
Any grade treatment related events ran 97.1% versus 89.6%. There were three treatment related deaths in each arm (0.8%). Merck reported no new safety signals and said health related quality of life was maintained. The toxicity trade is the part prescribers will weigh: a 13 point higher severe event rate against decades old chemotherapy, in exchange for nearly seven additional months of median survival.
How did the market react to the ESMO 2026 weekend?
Monday was the first trading session after the congress weekend, and only Amgen, holder of the weekend’s clearest new standard of care, closed higher among the five big presenters. Merck fell 3.2% despite the survival win and the dated priority review.
All closes are exchange settled closes for Monday, October 26; all percentages are our arithmetic against Friday’s closes; every row is a first reaction session to data presented at or around the ESMO weekend and is labeled as such. No cause is assigned to any move beyond the disclosures named.
| Ticker | Monday close | Move | Context |
|---|---|---|---|
| MRK | 140.61 | −3.2% | First session after the TroFuse-005 survival data, the PDUFA disclosure, and its oncology investor event; no company disclosure assigns the move |
| AMGN | 444.63 | +1.2% | First reaction to Saturday’s DeLLphi-305 first line small cell lung cancer data; the only gainer of the five |
| SMMT | 14.50 | −6.3% | First reaction to HARMONi-GI1, a China run biliary tract win over durvalumab; the US registration study activates this quarter |
| RHHBY | 59.98 | −1.9% | ADR print; first reaction to Sunday’s Krascendo 1 divarasib survival data, which carried no submission date |
| MRNA | 198.85 | −0.6% | Third session since the intismeran leak week; down 17.6% on the leak session |
| LYCA | 28.85 | −3.8% | Second session as a public company; still 60.3% above the $18.00 offer |
Context: the XBI closed at 150.47, up 0.6%, and the SPY at 765.37, up 0.7%. The weekend’s winners underperformed a rising tape, which is the pattern this week’s editions are tracking: removed uncertainty is getting paid, announced optionality is not.
What did Bristol Myers and SystImmune report for iza-bren at ESMO 2026?
Izalontamab brengitecan, the EGFR and HER3 directed bispecific antibody drug conjugate, cut the risk of progression 60% after EGFR TKI failure in NSCLC and 59% in heavily pretreated HR+/HER2− breast cancer in two Chinese Phase 3 trials, per ESMO presentations reported by Fierce Pharma. Overall survival is immature in both.
The figures below come from investigator presentations as reported by Fierce Pharma, not from company releases, and are attributed accordingly. In Panku-Lung01, run by original developer Sichuan Biokin in patients who progressed on a third generation EGFR TKI, median progression free survival was 11.1 versus 5.7 months against platinum chemotherapy, with a confirmed response rate of 60.2% versus 34.5% and duration of response of 10.5 versus 5.7 months; overall survival showed a favorable trend that was not statistically significant. In Panku-Breast01, covering HR+/HER2− breast cancer after endocrine therapy, CDK4/6 inhibition and chemotherapy, median progression free survival was 8.2 versus 4.0 months with a 40.5% versus 20.2% response rate. Chief medical officer Cristian Massacesi told Fierce the tally is now five positive Phase 3 trials from five in China, spanning nasopharyngeal, esophageal, triple negative breast, HR+/HER2− breast and EGFR mutant lung cancer. The US question is survival: Fierce notes the FDA told Summit that statistically significant overall survival is necessary for a filing in the comparable post TKI lung setting, and Bristol’s own global trials, Izabright-Lung01 and the first line Izabright-Lung02, read out from 2028.
Where does the KRAS G12D race stand between Incyte and Revolution Medicines?
Incyte’s INCB161734 posted a confirmed 81% response rate with modified FOLFIRINOX in 28 first line metastatic pancreatic cancer patients at ESMO, effectively matching the 82% Revolution Medicines reported for zoldonrasib earlier this year, per a Fierce Biotech interview with Incyte’s Pablo Cagnoni.
The Phase 1 data, with a July cutoff, also showed a 58% response rate in 26 patients on the gemcitabine and nab paclitaxel combination and a 36% response rate with median progression free survival of 7.2 months in 22 heavily pretreated colorectal cancer patients receiving the drug with Erbitux. All figures are from the conference presentation as reported by Fierce and are kept out of our headlines. Incyte has started a global Phase 3 in first line metastatic pancreatic cancer with topline expected in 2028, plans an adjuvant study, and plans a late stage colorectal trial next year. Cagnoni’s framing of the race with Revolution Medicines, whose Rasonque was approved in August for RAS mutant pancreatic cancer: neck and neck.
What does Anthropic’s IPO filing say about drug development?
Anthropic filed its S-1 on Monday to list on Nasdaq under the ticker ANT, and the filing discloses that the company is building its own molecular biology lab and investing in research that could eventually produce drug candidates, per Fierce Biotech’s report on the document.
Disclosure: BioMed Nexus drafts are produced with Anthropic’s Claude. We report the filing with attribution and take no view on the offering. Per Fierce Biotech’s read of the S-1, which our own fetch did not retrieve on Monday night, the filing describes a Claude for Life Sciences platform spanning early discovery through regulatory submissions, a Model Hardware Standard that lets AI agents operate microscopes, liquid handlers and robotic arms, and the April acquisition of computational biology startup Coefficient Bio for 15.4 million shares. Novo Nordisk and Bristol Myers Squibb are named as pharma partners, and Novartis chief executive Vas Narasimhan joined the board in April. The risk factors include biosafety and environmental liability, potential FDA oversight, model errors or hallucinations contributing to patient harm or compromised research, and the possibility that the company cannot explain why its models produce particular outputs. An August New York Times report, cited by Fierce, said the offering could raise more than $100 billion. In the same vertical this week, Boehringer Ingelheim and Microsoft announced an exploratory collaboration on AI digital patient twins for clinical trial design, including synthetic and hybrid control arms that could reduce conventional control group sizes, beginning in lung disease.
Who is in the biotech IPO queue now?
Windward Bio filed an F-1 on October 23 to list on Nasdaq as WWB, joining a queue behind Lycia’s $317.5 million debut. The Swiss company’s lead asset, WIN378, is an ultra long acting antibody against TSLP in Phase 2/3 for severe asthma.
Per the F-1, WIN378’s POLARIS-1 Phase 3 topline is expected in the first half of 2029, with a Phase 2 asthma readout in the first half of 2027 and the SIRIUS COPD topline in the second half of 2027; a TSLP and IL-13 bispecific, WIN027, is in Phase 1. Windward held $207.3 million in cash and equivalents at June 30 against up to $365 million raised from investors including OrbiMed, Novo Holdings and SR One, and the filing leaves share count and price range blank. Among last week’s issuers: Lycia closed Monday at 28.85, down 3.8% in its second session and still 60.3% above its $18.00 offer, our arithmetic. Zai Lab closed at 24.34, up 1.3%, with its placement expected to close on or about October 27 and no closing release found in Monday night’s checks. Disc Medicine’s offering closing release remains absent four days past the expected October 22 close; Monday night’s searches surfaced only a June 2023 closing release, a stale lookalike we identified and discarded.
What deals did Gilead and Roche announce late last week?
Gilead agreed on October 22 to acquire PepStar Therapeutics’ oral IL-23R inhibitor program, led by the Phase 1 peptide HCXT-2001, for $1.275 billion in cash at closing. Roche licensed Zymeworks’ DLL3 directed trispecific T cell engager ZW209 on October 23 for $55 million upfront.
Both items crossed after our Thursday build and were missed by the weekend sweep; they are printed here as dated catch ups, each verified against the company’s own release. Gilead’s deal covers worldwide rights to HCXT-2001, an investigational oral macrocyclic peptide inhibitor of IL-23R with an extended half life, aimed first at inflammatory bowel disease with potential in psoriasis; milestones were not disclosed, closing is expected in the fourth quarter of 2026, and Gilead flagged a GAAP and adjusted earnings reduction of roughly $0.79 to $0.83 per share in that quarter. Zymeworks receives $55 million upfront, $40 million when a Phase 1b trial starts, up to $718 million in development, commercial and sales milestones, and tiered royalties from high single digit to mid teen percentages; summing the disclosed components puts the package at about $813 million before royalties, our arithmetic, as the release states no total. ZW209 pairs DLL3 targeting with CD3 engagement and built in CD28 costimulation, a next generation approach to the target Amgen’s Imdelltra just validated in first line small cell lung cancer.
Frequently asked questions
What is sacituzumab tirumotecan (sac-TMT)?
Sac-TMT is a TROP2 directed antibody drug conjugate that Merck licensed from China’s Kelun. Merck is running 18 global Phase 3 trials of the molecule across tumor types, and TroFuse-005 in endometrial cancer is its first global Phase 3 survival win.
What did the TroFuse-005 trial show?
In 776 patients with previously treated advanced or recurrent endometrial cancer, sac-TMT extended median overall survival to 19.0 months versus 12.1 months for chemotherapy, a 32% reduction in the risk of death, and more than doubled the response rate, per Merck’s release and The Lancet publication.
What is the PDUFA date for sac-TMT in endometrial cancer?
June 15, 2027. The FDA accepted the Biologics License Application with priority review, covering endometrial cancer previously treated with platinum chemotherapy and a PD-1 or PD-L1 inhibitor.
Could the FDA approve sac-TMT before June 15, 2027?
Merck said it is hopeful for an approval before the target date based on discussions with the FDA, and the agency has repeatedly acted ahead of its 2026 action dates, in one case by nearly three months.
How did Merck’s stock react to the sac-TMT data?
Merck closed Monday, October 26 at 140.61, down 3.2% from Friday, our arithmetic, in the first session after the data, the PDUFA disclosure and its oncology investor event. No company disclosure assigns the move.
What were the main side effects of sac-TMT in TroFuse-005?
Grade 3 or higher treatment related events occurred in 54.4% of sac-TMT patients versus 41.4% on chemotherapy, led by anemia, neutropenia and stomatitis, with treatment related discontinuations lower on sac-TMT at 3.1%.
What is iza-bren?
Izalontamab brengitecan is a bispecific antibody drug conjugate directed at EGFR and HER3, developed by Sichuan Biokin through SystImmune and licensed by Bristol Myers Squibb. Its developers count five positive Phase 3 trials in China across five tumor types.
Why has Bristol Myers not filed iza-bren in the United States?
Overall survival remains immature in the Chinese Phase 3 trials, and Fierce Pharma notes the FDA has told Summit that statistically significant survival is necessary for a filing in the comparable lung cancer setting. Bristol’s global trials read out from 2028.
What is INCB161734?
INCB161734 is Incyte’s KRAS G12D inhibitor. At ESMO 2026 it posted a confirmed 81% response rate with modified FOLFIRINOX in 28 first line metastatic pancreatic cancer patients, per Fierce Biotech; a global Phase 3 is underway with topline expected in 2028.
What ticker will Anthropic trade under?
Anthropic filed to list on Nasdaq under the ticker ANT, per Fierce Biotech’s report on the S-1 filed October 26. The filing does not yet state an offering price or share count.
What does Anthropic’s S-1 say about making drugs?
Per Fierce Biotech’s read, the filing discloses an in house molecular biology lab, investment toward research that could eventually produce drug candidates, a hardware standard for AI agents operating lab equipment, and partnerships with Novo Nordisk and Bristol Myers Squibb.
What is Windward Bio?
Windward Bio is a Swiss biotech that filed an F-1 on October 23 to list on Nasdaq as WWB. Its lead asset WIN378 is an ultra long acting antibody against TSLP in Phase 2/3 for severe asthma and Phase 2 for COPD.
What did Gilead pay for PepStar’s HCXT-2001?
$1.275 billion in cash at closing for the oral IL-23R inhibitor program, with milestones undisclosed and closing expected in the fourth quarter of 2026, per Gilead’s October 22 release.
What is ZW209?
ZW209 is Zymeworks’ trispecific T cell engager targeting DLL3 with CD3 engagement and CD28 costimulation. Roche licensed it globally for $55 million upfront, $40 million at the Phase 1b start, and up to $718 million in milestones plus royalties, per Zymeworks.
When does ESMO 2026 end?
The ESMO Congress 2026 in Madrid holds its final sessions on Tuesday, October 27, 2026.
Sources
Primary sources: Merck press release on TroFuse-005 interim results and FDA priority review (October 26, 2026, Business Wire); Merck ESMO 2026 curtain raiser release (October 13, 2026); Windward Bio Group AG Form F-1 (SEC, filed October 23, 2026); Gilead Sciences press release on the PepStar HCXT-2001 acquisition (October 22, 2026); Zymeworks press release on the Roche ZW209 license (October 23, 2026); exchange settled closing prices for October 26, 2026 (percentage calculations are ours).
Trade press, attributed: Fierce Pharma on the Panku-Lung01 and Panku-Breast01 ESMO presentations and the Massacesi interview (October 26, 2026); Fierce Biotech on Incyte’s INCB161734 ESMO data and the Cagnoni interview (October 26, 2026); Fierce Biotech on Anthropic’s S-1 (October 26, 2026); Fierce Biotech on the Boehringer Ingelheim and Microsoft digital twin collaboration (October 26, 2026, announcement dated October 22).
