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)