The company said the US FDA has approved the additional indication for ALIMTA (pemetrexed for injection) plus
carboplatin and KEYTRUDA (pembrolizumab) for initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status.
IMpower133 is a Phase III, multicenter, double-blinded, randomized placebo- controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (
carboplatin and etoposide) versus chemotherapy (
carboplatin and etoposide) alone in chemotherapy-naive people with ES-SCLC.
The overall response rate for the
carboplatin regimen was 75.9%, with 36.1% complete responses.
Placebo and
carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for four cycles and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for four cycles or nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for four cycles, followed by placebo every 3 weeks.
The study, supported by the US National Cancer Institute (NCI), will evaluate the efficacy and safety of the combination of belinostat and
carboplatin, or BelCar, in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or peritoneal cancer.
Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development, said: "Our phase III results showed TECENTRIQ in combination with Avastin, paclitaxel and
carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer.
Eli Lilly (LLY) announced that the FDA has granted approval for a new indication for Alimta in combination with
carboplatin and Keytruda for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, or NSCLC, irrespective of PD-L1 expression status.
Switzerland-based Roche has indicated a clinically significant survival benefit in a phase III lung cancer study of its Tecentriq (atezolizumab) combined with Avastin (bevacizumab) plus
carboplatin and paclitaxel (chemotherapy), it was reported on Monday.
M2 PHARMA-November 2, 2018-FDA Approves US Merck's Keytruda in Combination with
Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)