11 September 2017 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) has released final overall survival data from the PROFILE 1014 trial examining Xalkori (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer(NSCLC), the company said.

After a median follow-up of 46 months, the median OS for patients randomised to Xalkori was not reached (95% CI: 45.8 months, not reached) and was 47.5 months for patients randomized to chemotherapy (95% CI:32.2 months, not reached).

Results indicated a numerical improvement in OS for patients treated with first-line Xalkori compared with chemotherapy, though this difference did not quite achieve statistical significance (HR=0.760 [95% CI: 0.548, 1.053]; p=0.0978).

These data [Abstract #LBA50] were presented TODAY at the 2017 European Society for Medical Oncology Congress in Madrid, Spain.

The majority of patients initially randomised to chemotherapy received Xalkori after they progressed and this likely affected the overall survival results.

A pre-specified, exploratory statistical analysis, adjusting for the effects of crossover, determined that median OS would have been longer for patients randomized to Xalkori than for patients randomised to chemotherapy, if patients had not been allowed to cross over [HR: 0.346 (95% CI: 0.081, 0.718)].

Overall survival was a secondary endpoint of PROFILE 1014 and the threshold for statistical significance was p≤0.0247.

PROFILE 1014 was a global, randomized, open-label, two-arm Phase 3 study that evaluated the efficacy and safety of XALKORI in patients with previously untreated ALK-positive advanced NSCLC.

Progression-free survival was the primary endpoint, and these results were previously published in The New England Journal of Medicine.

There was a statistically significant improvement in PFS in the patients treated with XALKORI than with chemotherapy (p