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October 19, 2020 // -- Merck Co) recently announced positive results for two clinical studies of the anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pabliju monoanti) lung cancer clinical development project: Keytruda combined chemotherapy (KEYNOTE-021 ) and Keytruda combined anti-CTLA-4 antibody quafonlimab (MK-1308).
in KEYNOTE-021 (Queue G), patients with advanced non-squamous non-small cell lung cancer (NSCLC) were evaluated for first-line treatment, regardless of PD-L1 expression level, and queue G patients were free of EGFR or ALC gene tumor abnormalities.
of 4 years (49.4 months) of medium follow-up, the results showed that keytruda combined chemotherapy (n-60) first-line therapy had significant efficacy compared to pure chemotherapy (n-63): (1) objective remission rate (ORR:58% vs 33%) was significantly increased, and medium remission duration (DOR) was extended by more than one year (36) .3 months) vs 22.8 months) ;(2) No progression lifetime (medium PFS: 24.5 months vs 9.9 months) was significantly extended, and the risk of disease progression or death was significantly reduced by 46% (HR=0.54 (95%CI:0.35-0.83).
, Keytruda combined chemotherapy showed long-term survival benefits.
50 percent of patients in the Keytruda plus chemotherapy group survived three years later, and 37 percent in the chemotherapy group.
addition, Keytruda plus chemotherapy reduced the risk of death by 29% (HR-0.71 (95% CI, 0.45-1.12) and significantly longer total survival (medium OS: 34.5 months vs. 21.1 months) compared to chemotherapy.
Although the effective crossover rate from chemotherapy to anti-PD-1/PD-L1 therapy was 70% (n-43/61), including 28 patients treated with Keytruda as part of the study cross-treatment, OS benefits were observed.
these findings represent the longest follow-up data for anti-PD-1/PD-L1 combination chemotherapy therapy for NSCLC.
particularly noteworthy is that 92% of patients who completed two years of treatment with Keytruda survived at 3 years (n-11/12).
all 12 patients received objective remission, with an estimated 3-year remission duration (DOR) rate of 100% (the median DOR did not reach the "NR"; range: 11.7 to 49.3 plus months).
follow-up found no new safety signals for Keytruda combined chemotherapy.
of all patients treated, 39 percent in the Keytruda plus chemotherapy group and 31 percent in the chemotherapy group had treatment-related adverse events (TRAEs) of level 3-5.
3-5 levels of TRAE resulting in drug suspension were 17 percent in the Keytruda plus chemotherapy group and 16 percent in the chemotherapy group.
3-5 levels of TRAE resulting in death were 2% in the Keytruda plus chemotherapy group (n=1) and 3% in the chemotherapy group (n=2).
addition, the latest follow-up data from the 1/2 study showed that quavonlimab in combined with Keytruda first-line treatment of patients with advanced NSCLC showed anti-tumor activity and showed acceptable safety.
, vice president of oncology clinical research at Mercedon Research Laboratory, said: "Over the past five years, Keytruda has become the foundational treatment for metastasis lung cancer.
Long-term data from KEYNOTE-021 (Queue G) reinforces the role of Keytruda in combination with chemotherapy in some patients with advanced lung cancer, and data from our Oncology Research Pipeline reflects our commitment to exploring a new combination of Keytruda that we believe could have a meaningful impact on more lung cancer patients.
The latest data from our anti-CTLA-4 antibody quavonlimab in combination with Keytruda supports the continued development of this new combination and plans to conduct Phase 3 studies on the combination of quavonlimab and Keytruda for the treatment of advanced non-small cell lung cancer.
"():Merck Presents Three-Year Survival Data for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308) in Combination With KEYTRUDA in Advanced Non-Small Cell Lung Cancer。