进一步，退两步

进一步，退两步……在个人的生活中，在民族的历史上，在政党的发展中，都有这种现象。

当然也包括临床研究。

一天之内默大先生连发了两则通告，第一则

身为统计学菜鸡，也能看出是统计背的锅，但具体细节因为菜，所以只能一言带过，另外就算不提统计，这种后线治疗双终点也够心中万头草泥马奔腾的，其中一个还是PFS。。。

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-240 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) compared with placebo plus best supportive care. In the final analysis of the study, there was an improvement in OS for patients treated with KEYTRUDA compared to placebo, however these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.78 [95% CI, 0.611-0.998]; p=0.0238). Results for PFS were also directionally favorable in the KEYTRUDA arm compared with placebo but did not reach statistical significance (HR=0.78 [95% CI, 0.61-0.99]; p=0.0209). The key secondary endpoint of objective response rate (ORR) was not formally tested, since superiority was not reached for OS or PFS. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and have been shared with the U.S. Food and Drug Administration for discussion.

Pembrolizumab单药≥3线治疗SCLC获得优先审批

申报基于SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials，介绍如下：

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 17, 2019.

“There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “KEYTRUDA has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients.”

This acceptance marks the first U.S. application for KEYTRUDA in SCLC and demonstrates Merck’s commitment to bringing forward new treatment options for patients with historically difficult-to-treat cancers, like SCLC. As part of our broad clinical development in lung cancer, KEYTRUDA is being studied in combination with chemotherapy in the ongoing Phase 3 KEYNOTE-604 study in patients with newly diagnosed extensive stage SCLC.