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Opdivo resumes indication expansion in NSCLC as first-line
by Eo, Yun-Ho Nov 03, 2020 05:58am
The pharmaceutical industry sources reported Ono Pharmaceutical and Bristol Myers Squibb (BMS) have recently submitted an application to expand indication on a programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in combination with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab) to treat patients with non-small cell lung cancer (NSCLC) as a first-line treatment. In last May, the U.S. Food and Drug Administration (FDA) has approved Opdivo plus Yervoy combination as a first-line therapy on NSCLC patients with programmed death-ligand 1 (PD-L1) expression over 1 percent. Also the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an approval recommendation on the combination therapy as well. The Phase 3 CheckMate-9LA study confirmed the efficacy of the Opdivo plus Yervoy combination treating patients with NSCLC as a first-line treatment. CheckMate-9LA is an open-label, multi-center, randomized Phase 3 trial that evaluated Opdivo plus Yervoy combined with two cycles of chemotherapy, compared to chemotherapy alone, as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology. In the study, study, the combination of Opdivo plus Yervoy plus two cycles of chemotherapy resulted in superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR), and met primary and secondary endpoints. An interim analysis following up the patients at least for 8.1 months found that the Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31 percent, compared to chemotherapy alone. Moreover, a longer follow-up of at least 12.7 months was able to verify the median OS of the Opdivo plus Yervoy combined with two cycles of chemotherapy marking 15.6 months, which continued to improve OS than the chemotherapy alone at 10.9 months. In the same extended follow-up, the combination therapy demonstrated improved OS regardless of PD-L1 expression. And in patient group with PD-L1 expression less than 1 percent, the risk of death was reduced by 38 percent, when the risk was reduced by 36 percent in patient group with over 1 percent expression. Comparing the combination therapy against the chemotherapy alone, the one-year PFS rate was at 33 percent and 17 percent, respectively, whereas their ORR were at 38 percent and 25 percent, respectively. In South Korea, Opdivo in combination with Yervoy, indicated to treat patients with renal cell carcinoma, is in process of seeking the healthcare reimbursement listing. In last June, the Cancer Deliberation Committee has passed the combination therapy.