Avelumab Yields No Survival Benefit in Platinum-Treated NSCLC

Avelumab did not improve overall survival (OS) compared with docetaxel when used for the treatment of patients with platinum-treated, PD-L1–positive non–small-cell lung cancer (NSCLC), according to results from the ongoing JAVELIN Lung 200 clinical trial (The Lancet Onc. 2018 Sept 24. Epub ahead of print).

“Antibodies targeting the immune checkpoint molecules PD-1 or PD-L1 have demonstrated clinical efficacy in patients with metastatic non-small-cell lung cancer,” stated Fabrice Barlesi, MD, PhD, Professor of Medicine, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, France, and colleagues, who sought to investigate the safety and efficacy of using avelumab, an anti–PD-L1 antibody, in patients with NSCLC who had already received platinum-based therapy.

JAVELIN Lung 200 Trial

The multicenter, open-label, phase 3 trial, JAVELIN Lung 200, enrolled 792 patients at 173 hospitals and cancer centers spanning 31 countries. Eligible patients were aged 18 years or older and had stage IIIB or IV or recurrent NSCLC that progressed after treatment with a platinum-containing doublet. Patients also had to have an Eastern Cooperative Oncology Group performance status score 0 or 1, an estimated life expectancy >12 weeks, and adequate hematological, renal, and hepatic function.

Patients were randomized in a 1:1 ratio to receive avelumab 10 mg/kg every 2 weeks or docetaxel 75 mg/m² every 3 weeks. Of the 792 patients enrolled in the study, 396 received avelumab and 396 received docetaxel. A total of 264 patients in the avelumab group and 265 in the docetaxel group had tumors that were PD-L1–positive.

The primary end point of the trial was OS. Efficacy was analyzed in all patients with PD-L1–positive disease, and safety was analyzed in all patients who received at least 1 dose of treatment.

Favorable Safety, Unfavorable Survival Benefits

The median OS did not differ significantly between patients with PD-L1-positive tumors in the avelumab and docetaxel arms (11.4 months vs 10.3 months, respectively).

Treatment-related adverse events occurred in 251 (64%) of 393 patients treated with avelumab and 313 (86%) of 365 patients treated with docetaxel; these included grade 3–5 events, which occurred in 39 (10%) and 180 (49%) patients in each arm, respectively. Serious treatment-related adverse events occurred in 34 (9%) patients who received avelumab and 75 (21%) patients who received docetaxel.

The most frequently reported adverse events included infusion-related reactions, increased lipase, neutropenia, and febrile neutropenia. Treatment-related mortality occurred in 4 (1%) patients in the avelumab arm and 14 (4%) patients in the docetaxel arm.

 “Compared with docetaxel, avelumab did not improve overall survival in patients with platinum-treated PD-L1-positive NSCLC, but had a favourable safety profile,” Dr Barlesi and colleagues concluded.—Janelle Bradley