FDA Accepts Application for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC

Excerpt:

“The FDA has accepted a supplemental biologics license application (sBLA) for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb), according to Bristol-Myers Squibb (BMS), the manufacturer of both immune checkpoint inhibitors.

“The sBLA is based on findings from the phase III CheckMate-227 trial presented at the 2018 AACR Annual Meeting and published in the New England Journal of Medicine, in which the 1-year progression-free survival (PFS) rate was 43% for patients with high TMB (≥10 mut/Mb) assigned to the immunotherapy combination compared with 13% for those assigned to platinum-doublet chemotherapy. The median PFS was 7.2 months versus 5.5 months, respectively, representing a 42% reduction in risk of disease progression or death (HR, 0.58; 97.5% CI, 0.41-0.81; P <.001).”

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FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018.

” ‘Our phase III results showed atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous non–small cell lung cancer,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech.”

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Frontline Pembrolizumab Combo Submitted for FDA Approval in Squamous NSCLC

Excerpt:

“The FDA has received a supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer (sNSCLC).

“The application is based on findings from the phase III KEYNOTE-407 trial (NCT02775435),  which evenly randomized 560 treatment-naive patients with metastatic squamous NSCLC to pembrolizumab combined with carboplatin/paclitaxel or nab-paclitaxel (Abraxane), carboplatin/paclitaxel alone, or nab-paclitaxel alone. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and duration of response.”

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US FDA Accepts Supplemental Biologics License Application for Imfinzi in Locally Advanced Unresectable Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.”

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