MRK · 8-K · 20260804PR090045
Product and Pipeline Progress
Merck & Co., Inc. · 2026-08-04 · Importance 31 · Surprise 42 · In source text
Merck received U.S. approvals for KEYTRUDA and KEYTRUDA QLEX combinations with WELIREG in adjuvant clear cell renal cell carcinoma, with Padcev before and after surgery in muscle-invasive bladder cancer, and with Trodelvy in first-line PD-L1-positive advanced triple-negative breast cancer. The Phase 3 TroFuse-005 trial of investigational sac-TMT met its overall-survival and progression-free-survival primary endpoints in advanced or recurrent endometrial cancer after platinum chemotherapy and anti-PD-1/L1 therapy. The company also reported positive Phase 3 results for the once-weekly oral islatravir/lenacapavir HIV regimen developed with Gilead. Regulatory approvals for ENFLONSIA in Japan and China expanded prevention of RSV lower respiratory tract disease in newborns and infants.
Key facts
- Company will hold an Oncology Investor Event on Monday, Oct. 26, 2026 at 6 p.m. CET / 1 p.m. EDT in Madrid, Spain source
- At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively, in the CORALreef trials source
- TroFuse-005 trial evaluating sacituzumab tirumotecan met its primary endpoints of overall survival and progression-free survival in advanced or recurrent endometrial cancer source
- Announced positive Phase 3 results from once-weekly investigational oral HIV regimen of islatravir and lenacapavir, in collaboration with Gilead source
- Merck presented first Phase 3 results for islatravir/lenacapavir showing maintained virological suppression in adults with HIV who switched antiretroviral therapy; ISL/LEN has potential to be first approved oral once-weekly HIV treatment source
- Phase 3 TroFuse-005 results are the first Phase 3 results from the company's sac-TMT program which includes 17 ongoing global Phase 3 trials source
- At ASCO 2026, five-year follow-up data from Phase 2b KEYNOTE-942 (with Moderna) underscored continued potential of intismeran autogene (mRNA-4157/V940) plus KEYTRUDA in stage III/IV melanoma post resection source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively, in the CORALreef trials |
| revenue | positive | probable | — | TroFuse-005 trial evaluating sacituzumab tirumotecan met its primary endpoints of overall survival and progression-free survival in… |
| revenue | positive | probable | — | Announced positive Phase 3 results from once-weekly investigational oral HIV regimen of islatravir and lenacapavir, in collaboration with… |