Merck (NYSE:MRK) announces data presentations at ESMO on pipeline candidates vibostolimab (MK-7684), MK-4830 and MK-6482.
Phase 1 study evaluating anti-TIGIT therapy vibostolimab, combined with Keytruda (pembrolizumab), in patients with non-small cell lung cancer (NSCLC) most of whom had received more than one prior line of therapy but none a PD-1/L1 inhibitor, showed a manageable safety profile and a 29% overall response rate (ORR). Median progression-free survival (PFS) was 5.4 months. Median duration of response (DOR) was not reached. In patients with PD-L1-positive (at least 1%) tumors, the ORR was 46% (n=6/13) while median PFS was 8.4 months. In patients with lower-expressing PD-L1 cancer (<1%), the ORR was 25% while medina PFS was 4.1 months. Median follow-up was 11 months.
Additional data on vibostolimab monotherapy and in combination with Keytruda in metastatic NSCLC patients whose progressed in prior anti-PD-1/L1 therapy again showed a manageable safety profile (there was one treatment-related death in each arm). The ORR was 7% in the monotherapy arm and 5% in the combo arm. Median DORs were 9 months and 13 months, respectively.
A Phase 3 study evaluating vibostolimab in NSCLC should launch in H1 2021.
Open-label Phase 1 trial assessing anti-ILT4 candidate MK-4830, alone and with Keytruda, in patients with solid tumors (51% had received at least three prior lines of therapy) showed an acceptable safety profile and dose-related evidence of target engagement. Results justify continued development.
Open-label Phase 2 study evaluating oral HIF-2 alpha inhibitor MK-6482 in patients with Von Hippel-Lindau (VHL)-associated renal cell carcinoma (RCC) showed a confirmed ORR of 36% (n=22/61). Median time to response was 31.1 weeks. Median DOR and median PFS were not reached. Median duration of treatment was 68.7 weeks. 91.8% of patients were still on therapy after minimum follow-up of 60 weeks.
In patients with non-RCC tumors and pancreatic lesions, the confirmed ORR was 64% (n=39/61) including four complete responders and 35 partials, while 21 showed stable cancer implying a disease control rate of 98% (n=60/61).
93.8% (n=15/16) of patients with retinal lesions experienced stable or improved responses.
On the safety front, 98.4% of participants experienced a treatment-related adverse event (mild, moderate or serious). Serious adverse events included anemia (6.6%), fatigue (4.9%) and dyspnea (shortness of breath) (1.6%).
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