FDA Grants Priority Review to Tecentriq Combo for First-Line Treatment of Advanced Lung Cancer

Excerpt:

“The U.S. Food and Drug Administration has granted priority review to Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy medications Taxol (paclitaxel) and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

“Priority review of Roche’s supplemental Biologics License Application means the FDA will decide whether or not to approve the therapy within six months instead of the standard 10 months. A decision is now expected by Sept. 5. To be granted priority review, a therapy candidate must show potential to provide significant benefits for the treatment, prevention, or diagnosis of a disease.”

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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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FDA Grants Priority Review to Keytruda as Part of Non-Small Cell Lung Cancer Regimen

Excerpt:

“The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with pemetrexed and platinum chemotherapy for the treatment of patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.

“Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”

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Frontline Atezolizumab Benefit in NSCLC Sustained Across Biomarker-Driven Subgroups

Excerpt:

“Adding atezolizumab (Tecentriq) to chemotherapy and an angiogenesis inhibitor led to significant improvement in progression-free survival (PFS) for patients with untreated advanced nonsquamous non–small cell lung cancer (NSCLC), according to results from an ongoing trial presented at the 2018 AACR Annual Meeting.

“In the IMpower150 trial, patients who received the PD-L1 inhibitor along with bevacizumab (Avastin) and chemotherapy had a median PFS of 8.3 months compared with 6.8 months with bevacizumab and chemotherapy. The difference translated into a 38% reduction in the hazard for progression or death (HR, 0.62; 95% CI, 0.52-0.74; P <.0001).”

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Opdivo Plus Low-Dose Yervoy Combination Reduces the Risk of Progression or Death by 42% Versus Chemotherapy in First-Line Lung Cancer Patients with High Tumor Mutational Burden (TMB)

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival (PFS) versus chemotherapy (HR 0.58; 97.5% CI: 0.41 to 0.81; p=0.0002). The PFS benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumor histology. Additionally, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB ≥10 mut/Mb (HR 0.79; 95% CI: 0.56 to 1.10).”

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Merck’s KEYTRUDA® (Pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumors were negative for PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of KEYTRUDA to pemetrexed plus platinum chemotherapy also achieved a significant improvement in progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination arm, compared with chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). A PFS improvement in the KEYTRUDA combination group was observed in patients whose tumors were negative for PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]). These results are being presented today in a plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #CT075), with simultaneous publication in The New England Journal of Medicine.”

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Neoadjuvant Nivolumab was Safe, Yielded Pathologic Responses in Patients With Resectable Lung Cancer

Excerpt:

“The anti-PD1 immunotherapy nivolumab (Opdivo) given prior to surgical resection of stage 1-3 non-small cell lung cancer (NSCLC) was safe and resulted in major pathological responses in 45 percent of the patients, according to data from a clinical trial presented at the AACR Annual Meeting 2018, April 14-18.

“A major pathologic response is defined as 10 percent or fewer viable cancer cells detectable in the resected tumor following neoadjuvant treatment.”

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FDA Grants Opdivo Priority Review for Small Cell Lung Cancer

Excerpt:

“The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.

“The sBLA is based on data from the phase 1/2 CheckMate-032 trial, in which single-agent Opdivo led to a median overall survival (OS) of 4.4 months and a one-year OS rate of 33 percent in patients with progressive SCLC following one or more prior lines of therapy. Under the priority review, the FDA is scheduled to make its decision by Aug. 16, 2018.”

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