The addition of Tecentriq (atezolizumab) to first-line treatment with Avastin (bevacizumab) and chemotherapy does not significantly extend survival without disease worsening in people with newly-diagnosed advanced ovarian cancer, a recent trial shows.
While the IMagyn050 Phase 3 trial (NCT03038100) failed to meet one of its primary endpoints, researchers are gathering more data to determine whether the Tecentriq combo increases survival times, either in the overall trial population or in a subgroup whose cancers are positive for the PD-L1 protein.
“Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages,” Levi Garraway, MD, PhD, Roche’s chief medical officer, said in a press release. “While we are disappointed by these results, we remain committed to improving outcomes for women living with this disease and are pleased that Avastin remains a key component in the treatment of front-line ovarian cancer.”
People with advanced ovarian cancer are normally treated with surgery, followed by a combination of chemotherapy and Avastin, an antibody that interferes with the tumor blood supply, depriving cancer cells of oxygen and nutrients.
But evidence suggests that outcomes may be markedly improved if an immunotherapy that boosts the immune system into fighting cancer is added to the chemo-Avastin combo.
Tecentriq, developed by Roche subsidiary Genentech, is one such immunotherapy that has been deemed safe in ovarian cancer patients. It binds to the PD-L1 protein at the surface of cancer cells and prevents it from interacting with its receptor, PD-1, in immune cells, thereby keeping immune cells active and able to fight cancer.
Tecentriq and Avastin are also thought to act synergistically to enhance the immune system’s response to ovarian cancer cells.
IMagyn050 was designed to determine the safety and efficacy of Avastin and chemo — paclitaxel and carboplatin — with and without Tecentriq in people with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Conducted by Roche, in collaboration with the GOG Foundation and the European Network of Gynaecological Oncological Trial groups, the trial enrolled about 1,300 participants who either received treatment only after initial surgery, or were treated before and after surgery.
Participants were randomly assigned to Tecentriq or a placebo, given along with Avastin and chemo for six cycles. This was followed by maintenance therapy with Tecentriq plus Avastin, or Avastin plus a placebo, for 22 additional cycles (or 16 cycles for those receiving treatment before surgery).
The primary goal was to determine if Tecentriq extended the time patients lived without signs of disease progression and lengthened their overall survival, both in the global population and in the PD-L1-positive subgroup.
Despite the trial failing to meet its progression-free survival endpoint, data collection on overall survival is still ongoing, and follow-up with patients will continue until the next planned analysis, the company said.
Top-line analysis showed that the safety of adding Tecentriq to Avastin, paclitaxel, and carboplatin was consistent with the known safety profile of the combination.
An ongoing Phase 3 trial, called ATALANTE (NCT02891824), is evaluating a similar combination but in patients who received one or two prior lines of chemotherapy, and whose cancer returned six months or more after their last platinum-based chemotherapy regimen. Top-line data is expected by mid-2021.