FDA grants priority review to cancer therapies
The FDA granted priority review designation to several therapies in development for oncology indications.
- Atezolizumab (Tecentriq, Genentech/Roche) as first-line treatment for patients with advanced nonsquamous or squamous non-small cell lung cancer without EGFR or ALK mutations and with high PD-L1 expression.
The FDA based its decision on data from the phase 3 IMpower110 study, which demonstrated improved OS with atezolizumab — a PD-L1 inhibitor — compared with platinum-based chemotherapy among patients with high PD-L1 expression (20.2 months vs. 13.1 months; HR = 0.59; 95% CI, 0.39-0.89).
Researchers reported no new safety signals related to atezolizumab. A greater percentage of patients assigned chemotherapy vs. atezolizumab experienced grade 3 to grade 4 treatment-related adverse events (44.1% vs. 12.9%).
“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in OS compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the release. “We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible.”
The FDA is expected to make a decision on this application by June 19.
- Pembrolizumab (Keytruda, Merck) for treatment of adults and children with unresectable or metastatic solid tumors that have high tissue tumor mutational burden.
The designation applies to use of pembrolizumab — an anti-PD-1 therapy — for patients whose tumors have at least 10 mutations per megabase as determined by an FDA-approved test, who progressed after prior treatment and who have no satisfactory alternative treatments.
“From the start, biomarker research has been a critical aspect of our clinical program evaluating Keytruda monotherapy,” Scot Ebbinghaus, MD, vice president for clinical research with Merck Research Laboratories, said in a company-issued press release. “Tumor mutational burden has been an area of scientific interest to help identify patients most likely to benefit from Keytruda. We look forward to working with the FDA throughout the review process to help bring Keytruda monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited.”
The supplemental biologics license application is based in part on results of the nonrandomized, multicohort phase 2 KEYNOTE-158 trial.
Results showed an association between tumor mutational burden and outcomes among patients with select advanced solid tumors who received pembrolizumab dosed at 200 mg every 3 weeks.
The FDA is expected to make a decision on approval by June 16.
- Tafasitamab (MOR208, MorphoSys AG) — an investigational, humanized Fc-engineered monoclonal antibody directed against CD19 — in combination with lenalidomide (Revlimid, Celgene) for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
The FDA based the designation on data from the single-arm, phase 2 L-MIND trial — which evaluated tafasitamab in combination with lenalidomide for patients with relapsed or refractory DLBCL who received up to two prior lines of therapy — and a retrospective observational matched control cohort in the Re-MIND trial, which evaluated lenalidomide monotherapy for relapsed or refractory DLBCL in an attempt to isolate the contribution of tafasitamab.
Results showed a statistically significant improvement in best overall response rate with tafasitamab plus lenalidomide compared with lenalidomide alone.
- Nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) combined with a limited chemotherapy course as first-line treatment for patients with metastatic or recurrent NSCLC.
The designation applies to use of the regimen for patients with no EGFR or ALK genomic tumor aberrations.
Nivolumab is an anti-PD-1 antibody, and ipilimumab is an anti-CTLA-4 antibody. The combination is approved in the United States for treatment of certain patients with melanoma, renal cell carcinoma, colorectal cancer and hepatocellular carcinoma.
The FDA granted priority review to the lung cancer indication based on results of the randomized phase 3 CheckMate -9LA trial, which assessed the combination as first-line treatment for patients with metastatic NSCLC regardless of PD-L1 expression or histology.
Researchers assigned patients in the experimental treatment group to nivolumab dosed at 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks, combined with two cycles of chemotherapy. Treatment continued for up to 2 years or until disease progression or unacceptable toxicity.
Patients in the control group received up to four cycles of chemotherapy alone, followed by optional pemetrexed maintenance therapy if eligible until disease progression or toxicity.
The study met its primary endpoint of improved OS in the intent-to-treat population.
“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for [patients with lung cancer],” Sabine Maier, MD, development lead for thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “We look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”
The FDA is expected to make a decision on approval by Aug. 6.