Mursadong suffered a rare failure! The phase III study of keytruda + chemotherapy in the treatment of extensive small cell lung cancer (es-sclc) did not prolong the survival period!

January 8, 2020 / bioun / -- cancer immunotherapy giant Merck & Co recently announced the results of keytruda (Coretta, common name: pembrolizumab, pabolizumab) combined with chemotherapy in the first-line treatment of extensive non-small cell lung cancer (es-sclc) phase III keynote-604 study (nct03066778) The study was a randomized, double-blind, placebo-controlled trial conducted in 453 newly diagnosed es-sclc patients to evaluate the efficacy and safety of keytruda combined chemotherapy (etoposide + platinum containing chemotherapy [carboplatin or cisplatin]), single chemotherapy (etoposide + platinum containing chemotherapy [carboplatin or cisplatin]) The study had two main endpoints: total survival (OS) and progression free survival (PFS) Secondary endpoints included objective response rate (ORR), duration of response (DOR), safety, quality of life (QOL) The results showed that the study reached one of the dual primary endpoints: a statistically significant improvement in PFS was observed in the keytruda + chemotherapy combination group compared to the chemotherapy group (HR = 0.75 [95% CI: 0.61-0.91]) In terms of the other primary end point OS, keytruda + chemotherapy combined therapy group improved compared with the chemotherapy group, but the data did not reach the statistical significant difference of the predetermined statistical plan (HR = 0.80 [95% CI: 0.64-0.98]) In this study, keytruda's security is consistent with the previously reported results The results of the study will be presented at an upcoming medical conference and will be discussed with regulators Dr Roy Baynes, senior vice president and director of global clinical development of moshadong research laboratory, said: "extensive small cell lung cancer is a highly invasive cancer The results of keynote-604 show the potential of keytruda combined with chemotherapy, which can improve the prognosis of newly diagnosed patients with extensive small cell lung cancer We sincerely thank the patients and researchers who participated in this study and are committed to helping patients with refractory lung cancer " At present, MSD is the absolute leader in the field of tumor immunotherapy, and its anti PD-1 inhibitor keytruda has been approved for more than 20 treatment indications In addition to the five indications that have been approved for lung cancer, the company continues to study keytruda's role in multiple environments and stages of lung cancer through an extensive clinical project, which includes 20 clinical trials sponsored by MSD, involving more than 10000 patients According to the World Health Organization (who), lung cancer is the leading cause of cancer death in the world It causes nearly 1.8 million deaths every year, which means more than 4800 people die every day There are two main types of lung cancer, non-small cell lung cancer (NSCLC) and SCLC SCLC accounts for about 15% of lung cancer cases SCLC is an aggressive disease that is often not detected until the cancer progresses to the advanced stage Chemotherapy (combined with or without radiotherapy) has always been the standard first-line care plan However, most patients relapse within one year It is estimated that in the United States, the 5-year survival rate of slcl patients diagnosed at any stage is 6% In March 2019, tecentriq, Roche's PD-L1 tumor immunotherapy, was approved by FDA of the United States Combined chemotherapy (carboplatin + etoposide) was used to treat adult patients with extensive non-small cell lung cancer (es-sclc) This approval makes tecentriq combined chemotherapy (carboplatin + etoposide) the first and only cancer immunotherapy approved for early treatment of es-sclc, and also the first new first-line treatment scheme approved by FDA for es-sclc patients in the past 20 years Compared with chemotherapy, tecentriq + chemotherapy significantly prolonged the overall survival (median OS: 12.3 months vs 10.3 months; HR = 0.70, 95% CI: 0.54-0.91, P = 0.0069) and progression free survival (median PFS: 5.2 months vs 4.3 months, HR = 0.77, 95% CI: 0.62-0.96, P = 0.017) At present, AstraZeneca PD-L1 tumor immunotherapy imfinzi (durvalumab) combined with the supplementary biological product license application (SBLA) of platinum chemotherapy first-line treatment es-sclc is undergoing the priority review of the US FDA, and is expected to be approved in the first quarter of 2020 In the phase III CASPIAN study, compared with the chemotherapy group, the total survival time of imfinzi + chemotherapy group was significantly longer (median OS: 13.0 months vs 10.3 months), which was comparable to the OS results of Roche tecentriq in the phase III impower 133 study Previously, some analysts pointed out that if the phase III keynote-604 research can be successful, keytruda will pose a real threat to tecentriq in the field of es-sclc first-line treatment However, the study unexpectedly failed For Roche, tecentriq's position in the field of first-line treatment of es-sclc has been strengthened due to the failure of MSD Source of original text: Merck's keytruda ® (pembrolizumab) in combination with chemotherapy signally improved progression free survival compared to chemotherapy alone as first line treatment for extended stage small cell lung cancer