Roche has announced results from the global phase III ALUR study showing that Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.

“The strikingly positive results from the ALUR study across multiple endpoints provide strong further evidence of the efficacy of Alecensa in this setting,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We believe this robust data will support access to Alecensa for patients with ALK-positive lung cancer.”

The ALUR data will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress on Monday 11 September 2017, at 09:30-10:30 CET (Abstract #1299O).

The phase III ALUR study also demonstrated:

An overall response rate (ORR) of 36.1% for Alecensa versus 11.4% for chemotherapy (95% CI 0.05–0.43). Central nervous system (CNS) ORR in patients with measurable disease of 54.2% for Alecensa versus 0% for chemotherapy (95% CI 0.23–0.78). A disease control rate of 80.6% for Alecensa versus 28.6% for chemotherapy (95% CI 0.33–0.69), A median duration of response (DOR) of 9.3 months for Alecensa (95% CI 6.9–not estimable [NE]) versus 2.7 months with chemotherapy (95% CI NE).

Adverse events (AEs; all grades) occurred in 77.1% Alecensa patients compared with 85.3% chemotherapy patients, with Grade 3–5 AEs in 27.1% and 41.2%, respectively. There was one fatal AE in the chemotherapy arm, with none in the Alecensa arm.

AEs leading to discontinuation or dose reduction occurred in 10% patients in the Alecensa arm versus 20.6% in the chemotherapy arm.

Alecensa is approved as a monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan. Alecensa is also approved in Japan for patients whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). In the United States, Alecensa was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.

ALUR (NCT02604342) is a randomised, multi-centre, open-label phase III study evaluating the efficacy and safety of Alecensa versus chemotherapy (pemetrexed or docetaxel) in patients with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib. Patients were randomised (2:1) to receive either Alecensa or chemotherapy. The primary endpoint of the ALUR study is PFS and secondary endpoints include: overall survival (OS), CNS ORR in patients with measurable brain metastases at baseline and median time to CNS progression. The multicentre study was conducted in 107 patients across 15 countries.