Merck & Co Inc（MRK）资讯与事件MRKMerck & Co Inc

Merck's KEYTRUDA Phase 3 Trial Results Show Significant Improvement

Merck announced the first presentation of results from the Phase 3 KEYNOTE-C93 trial, evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with mismatch repair deficient advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence after receiving prior adjuvant therapy. Results showed KEYTRUDA as monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival for these patients, reducing the risk of disease progression or death by 43% compared to platinum doublet chemotherapy. These late-breaking results will be presented during a Presidential Symposium at the European Society for Medical Oncology Congress 2026, were selected for an official ESMO press briefing and were published simultaneously in The Lancet. After a median follow-up of 36.7 months, median PFS was 38.2 months for KEYTRUDA versus 8.4 months for chemotherapy, with 36-month PFS rates of 52.8% versus 30.0%, respectively. In addition to an improvement in PFS, a favorable trend in overall survival, the trial's other primary endpoint, was observed for KEYTRUDA monotherapy versus platinum doublet chemotherapy. Median OS was not reached for KEYTRUDA versus NR for chemotherapy, with 36-month OS rates of 70.7% versus 62.0%, respectively. The trial is continuing, and follow-up of OS is ongoing. Results will be shared with regulatory authorities worldwide. Confirmed objective response rate, a key secondary endpoint, was 64.1% with KEYTRUDA versus 62.1% with chemotherapy; complete response rates were 33.8% and 26.2%, respectively. ORR was not tested for statistical significance at this analysis. Among responders, median duration of response (DOR) was not reached for patients receiving KEYTRUDA versus 10.2 months for patients receiving chemotherapy; the 24-month DOR rate was 77.0% versus 41.3%, and the 36-month DOR rate was 70.7% versus 40.0%, respectively. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies, and no new safety signals were identified in either treatment arm. Grade greater than or equal to3 treatment-related adverse events occurred in 18.1% of patients receiving KEYTRUDA versus 50.7% of patients receiving chemotherapy; the most common Grade greater than or equal to3 TRAE was anemia, occurring in 2.0% of patients receiving KEYTRUDA compared with 18.1% of patients receiving chemotherapy. Grade greater than or equal to3 immune-mediated adverse events and infusion reactions occurred in 7.4% of patients receiving KEYTRUDA and 3.5% of patients receiving chemotherapy.

Merck Reports Key Results for sac-TMT, Extending Survival by 6.9 Months

Merck announced the first presentation of results from the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan, or sac-TMT, an investigational TROP2-directed antibody-drug conjugate being developed in collaboration with Kelun-Biotech, in patients with advanced or recurrent endometrial cancer who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. At a pre-specified interim analysis, the study demonstrated statistically significant and clinically meaningful improvement in its dual primary endpoints of overall survival and progression-free survival as well as its key secondary endpoint of objective response rate compared with treatment of physician's choice. "TroFuse-005 is the first global Phase 3 trial and the first ADC to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients with advanced or recurrent endometrial cancer," the company stated. These late-breaking data will be presented for the first time today during a Presidential Symposium session at the European Society for Medical Oncology Congress 2026, were selected for an official ESMO press briefing, and were published simultaneously in The Lancet. At the time of analysis, with a median follow-up of 14.0 months, sac-TMT reduced the risk of death by 32%, extending median OS by 6.9 months compared with TPC. Sac-TMT also reduced the risk of disease progression or death by 41%, extending median PFS by 3.3 months compared with TPC. The study improved ORR by 17.8%, double what was observed in the TPC arm, and complete responses occurred in 6.1% of patients on the sac-TMT arm and 4.5% of patients on the chemotherapy. Responses were durable, with a median duration of response of 11.1 months in the sac-TMT arm and 6.9 months in the TPC arm. "Sac-TMT demonstrated an improvement in overall survival of almost seven months for women with endometrial cancer who progress following treatment with platinum-based chemotherapy and anti-PD-1 therapy, a meaningful advancement for these women who face a median survival of less than a year with current therapies. We believe sac-TMT, with its unique bifunctional linker, can become a cornerstone for the treatment of certain patients with advanced or recurrent endometrial cancer. Based on discussions with the U.S. FDA, the company is hopeful for an approval before the PDUFA date to bring sac-TMT to patients as quickly as possible," said Dr. Dean Y. Li, president, Merck Research Laboratories.

TuHURA Biosciences Reports Initial Data on IFx-2.0

TuHURA Biosciences announced initial data from the first three patients in its open-label study of IFx-2.0 as an adjunctive therapy to Keytruda in first-line treatment of metastatic Merkel Cell Carcinoma. Results showed that each patient achieved a major objective anti-tumor response, with all three responses meeting the criteria for partial response under RECIST v.1.1 criteria. All responses were durable, as each of the responses were ongoing at the protocol-specified six-month assessment. The Phase 1b/2a trial of IFx-2.0 is a multicenter, open-label trial designed to assess the safety and feasibility of IFx-2.0 as adjunctive therapy to Keytruda when administered into deep seated and/or bulky tumors accessible with CT or ultrasound guided administration in the front-line treatment of adult patients with metastatic MCC. The trial is designed to initially enroll a total of nine patients with visceral tumors including hepatic, pulmonary, or retroperitoneal or other deep seated locations using CT or ultrasound guided administration where standard-size injection needles are unable to effectively administer the intended dose of IFx-2.0. Each patient received IFx-2.0 injected into a single deep-seated or bulky tumor once a week for three weeks. Within 48 hours of the first IFx-2.0 injection, patients received Keytruda, followed by Keytruda every three weeks until the earlier of disease progression, toxicity, or 2 years. Keytruda is approved as the front-line standard of care for patients with advanced or metastatic MCC. The primary endpoint of the study is safety and feasibility of IFx-2.0 therapy evaluated 28 days following the last dose of IFx-2.0, which is 49 days from the first IFx-2.0 infusion. The study will also evaluate key secondary endpoints, including efficacy per RECIST1.1 criteria at three and six months. "While preliminary and only reported in 3 patients, these results highlight that it is feasible to utilize CT or ultrasound guided administration of IFx-2.0 safely to patients with large bulky and or deep-seated tumors. This is also the first time we have administered IFx-2.0 with Keytruda(R) in the front line treatment setting of patients with metastatic MCC and may serve as a proxy to the potential response rates in the ongoing randomized placebo controlled Phase 3 trial, which is also being conducted in the front line treatment of patients with advanced or metastatic MCC as an adjunct with Keytruda," said Dr. James Bianco, President and Chief Executive Officer at TuHURA Biosciences. "Approximately 30% of patients with metastatic MCC present without cutaneous or superficial nodal involvement. If we continue to see this high response rate in patients in this trial, we will explore the potential to expand the number of patients in the trial and discuss with the FDA its potential to supplement the ongoing Phase 3 trial, should that study successfully meet the primary endpoint. We look forward to additional patient data in the coming months, and we will seek to present the data at an appropriate scientific conference next year."