Dive Brief:
- Novartis last week posted positive Phase 3 trial results for its lung cancer drug Zykadia (certinib) in previously untreated patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).
- The positive top line findings set up a potential showdown with Roche, which is also testing its drug Alecensa (alectnib) for first-line treatment of ALK+ NSCLC. Both firms are seeking to catch up to Pfizer’s Xalkori (crizotinib) — the standard option for first-line use.
- Following the results, Novartis said it would move forward with global regulatory submissions for Zykadia. ALK+ NSCLC affects between 2% and 7% of the roughly 1.8 million new lung cancer cases reported annually, according to the company.
Dive Insight:
In the newly released Phase 3 data, patients treated with Zykadia showed a significant improvement in their chance of surviving without the cancer spreading compared with standard chemotherapy, Novartis said. Zykadia also extended progression-free survival when compared with standard chemotherapy, according to the topline results.
In the study, 376 patients were randomized to receive Zykadia orally at 750 mg/daily or standard chemo. Detailed data will be presented at an upcoming major medical congress.
Novartis indicated it would share the data with regulatory authorities in the coming months. The timing is significant, as Roche is racing to win approval for its own drug Alecensa.
Zykadia has already been granted accelerated approval for the treatment of patients with ALK-positive NSLC who are intolerant to Xalkori.
Roche’s Alecensa was granted accelerated approval by the FDA in December 2015, and has shown positive results in comparison to Xalkori.
In May, Roche said its drug reduced the risk of disease worsening or death by 66% compared to Xalkori in a Phase 3 study among Japanese people.
Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including NSCLC.