The first-line treatment of extensive small cell lung cancer with K drug failed to significantly prolong OS

Original: Vegetables Today, mosadong announced that its star PD-1 drug, pembrolizumab (trade name: Coretta / keytruda, referred to as K drug), failed to beat chemotherapy in the keynote-604 trial with chemotherapy (etoposide + platinum drugs) to significantly improve the overall survival period (OS) of small cell lung cancer patients and missed a major end point, but the combination of K drug and chemotherapy significantly reduced the progression wind compared with chemotherapy Insurance (HR = 0.75), reaching another main destination Affected by the news, MSD shares fell 2.6% today Keynote-604 is a randomized, double-blind, placebo-controlled K drug and etoposide / platinum drugs (cisplatin / carboplatin) combined with the first-line treatment of extensive small cell lung cancer phase III clinical trial The keynote-604 study enrolled 453 patients with extensive small cell lung cancer who had not received systematic treatment before They were treated with cisplatin / carboplatin or cisplatin / carboplatin + K respectively There were two main end points, total survival (OS) and progression free survival (PFS) (source: clinical trials) SCLC accounts for 15% of lung cancer, which is totally different from NSCLC About 30% - 40% of small cell lung cancer is diagnosed as a limited period, after treatment, about 70% of patients will relapse PD-1 / PD-L1 antibody is suitable for the treatment of extensive small cell lung cancer 90% of all small cell lung cancer patients are relapsed or initially diagnosed The drugs are different according to whether there is metastasis or not and the location of metastasis It is worth mentioning that keytruda has been approved to treat extensive small cell lung cancer with single drug and second-line treatment based on the data of clinical phase II trials The orr is 19%, and 56% of the patients have a remission time of more than 18 months In addition, tecentriq and opdivo were approved for first-line and third-line treatment of extensive small cell lung cancer, respectively Patients in the phase III trial of tecentriq combined with first-line chemotherapy for extensive small cell lung cancer successfully prolonged OS and PFS Opdivo was approved for three-line treatment indications, but the clinical phase III trial of single drug and two-line treatment failed, and OS did not extend Similarly, the maintenance treatment indications of patients after chemotherapy did not succeed (source: ASCO) It is worth mentioning that, although the expression level of PD-L1 in SCLC is lower than that in NSCLC, tecentriq and imfinzi, two PD-L1 drugs, reduced the risk of death by 27% and 30% respectively compared with chemotherapy in impulse-133 and Caspian trials of similar design and similar patients, and prolonged the total survival period of 2.0 and 2.7 months Of course, drug K also reduced the risk of death by 20%, but did not meet the pre-set statistical criteria In China, PD1 / PD-L1 antibody is mainly focused on the first-line treatment of small cell lung cancer Roche started clinical phase III at the earliest From November 2018 to July 2019, five products including treprizumab started clinical phase III trials, with a similar progress In addition, the imported products are also carrying out phase III clinical trials on the patients with limited period and maintenance treatment indications, and Hengrui has carried out phase II clinical trials on the combination of apatinib for the second-line treatment indications.