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FDA grants priority review to Tecentriq combination for advanced triple-negative breast cancer
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The FDA granted priority review to a supplemental biologics license application that seeks approval of atezolizumab in combination with nab-paclitaxel for first-line treatment of unresectable locally advanced or metastatic PD-L1-positive, triple-negative breast cancer.
The FDA based the designation on results from the randomized phase 3 IMpassion130 study, which included 902 patients with previously untreated metastatic triple-negative disease.
Results of the study, presented in October at European Society for Medical Oncology Congress, showed the addition of the PD-L1 inhibitor atezolizumab (Tecentriq, Genentech) to nab-paclitaxel (Abraxane, Celgene) increased PFS in the intention-to-treat population of patients with unresectable locally advanced or metastatic triple-negative breast cancer (median, 7.2 months vs. 5.5 months; HR = 0.8; 95% CI, 0.69-0.92). The combination also improved PFS compared with nab-paclitaxel alone in the subgroup of patients with PD-L1-positive disease (HR = 0.62; 95% CI, 0.49-0.78).
Researchers reported median OS in the intention-to-treat population of 21.3 months with the atezolizumab regimen vs. 17.6 months with nab-paclitaxel alone. The difference did not reach statistical significance (HR = 0.84; 95% CI, 0.69-1.02).
However, results showed a significant OS improvement with the atezolizumab regimen in the PD-L1-positive subgroup (median, 25 months vs. 15.5 months; HR = 0.62; 95% CI, 0.45-0.86).
Serious adverse events were reported among 23 percent of patients who received atezolizumab plus nab-paclitaxel, compared with 18 percent who received nab-paclitaxel alone.
The FDA is expected to make a decision on this application by March 12.
“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” Sandra Horning, MD, executive vice president, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”– by John DeRosier