Media Thread, page-2834

Note these approvals in the PD1 and HER2 space. Given on PFS . I expect that Imugenes B cell immunotherapy and CF33 will match these, or better, WITHOUT toxicity.
TNBC will be first. C’mon, let’s get CHECK vacc started!

Merck Nets Two Keytruda Approvals in Japan for TNBC, Colon CancerAug 26, 2021 | staff reporterSave for laterNEW YORK – Merck said on Thursday that Japanese regulators have approved the firm's anti-PD-1 agent pembrolizumab (Keytruda) for two new indications: PD-L1-positive triple-negative breast cancer (TNBC) and microsatellite instability (MSI)-high colorectal cancer.The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has approved pembrolizumab combined with chemotherapy for patients with inoperable or recurrent, PD-L1-positive, hormone receptor-negative, HER2-negative breast cancer and pembrolizumab monotherapy for unresectable, advanced, or recurrent, MSI-high colorectal cancer. To approve the TNBC indication, the PDMA reviewed results from the Phase III KEYNOTE-355 trial, in which pembrolizumab plus chemotherapy improved progression-free survival versus chemotherapy alone for patients whose tumors expressed PD-L1 with a combined positive score of at least 10. The median progression-free survival time in this trial was 9.7 months with the immunotherapy combo compared to 5.6 months with chemo alone. According to Merck, overall survival results from KEYNOTE-355 will be presented at an upcoming medical meeting.The PDMA approved the colorectal cancer indication based on the results of the KEYNOTE-177 trial, in which pembrolizumab reduced the risk of disease progression or death by 40 percent versus standard-of-care chemotherapy. Median progression-free survival for patients treated with the checkpoint inhibitor was 16.5 months compared to 8.2 months among patients who received standard-of-care chemo. These approvals in Japan come after the US Food and Drug Administration last month converted its prior accelerated approval of the PD-L1-positive, advanced TNBC indication into full approval, and approved pembrolizumab last year as a first-line treatment for MSI-high or mismatch repair deficient metastatic colorectal cancer.In the PD1, and HER2 field, note these approvals, based on PFS