medwireNews: This month we bring you a round-up of four trials investigating nivolumab in diverse tumors, including non-small-cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal carcinoma. Read on to find out more.
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Scott Gettinger (Yale University School of Medicine, New Haven, Connecticut, USA) and colleagues report the 5-year results of the phase I CA209-003 trial of nivolumab in pretreated patients with advanced NSCLC.
They found that 16% of 129 patients who received the PD-1 inhibitor at a dose of 1, 3, or 10 mg/kg every 2 weeks for up to 96 weeks were alive at the 5-year mark.
Writing in the Journal of Clinical Oncology, the authors describe the overall survival (OS) rate as “unprecedented” for this patient population and note that it “compares favorably” with historic rates of 1–8% for stage IV NSCLC.
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Also reported in the same journal are the extended follow-up results of the phase II CheckMate 205 trial, in which nivolumab 3 mg/kg was given every 2 weeks to 243 patients with relapsed or refractory Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation.
Over a median of 18 months, the majority (69%) of participants achieved an objective response, which lasted a median of 16.6 months.
Lead author Philippe Armand (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) and colleagues highlight that “[s]ustained benefits were seen across different patient populations, including patients refractory to prior therapies and patients with and without prior [brentuximab vedotin] exposure.”
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Phase II results – also appearing in the Journal of Clinical Oncology – indicate that nivolumab has promising activity in pretreated patients with recurrent or metastatic nasopharyngeal carcinoma.
Among 44 patients (83% Asian) who had received a median of three prior therapies, the objective response rate with nivolumab 3 mg/kg every 2 weeks was 20.5%, with one complete and eight partial responses.
The 1-year OS rate was 59%, which is favorable compared with other phase II trials in similar populations, which have reported rates of around 45% in response to cytotoxic and noncytotoxic drugs, say Brigette Ma, from The Chinese University of Hong Kong, and co-investigators.
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Finally, the IL-15 superagonist ALT-803 “represents a novel immunotherapeutic agent that could augment the anti-tumour activity of checkpoint inhibitors,” say researchers who found that the combination of ALT-803 and nivolumab is well tolerated and has activity against previously treated stage IIIB–IV NSCLC.
As reported by Mark Rubinstein (Medical University of South Carolina, Charleston, USA) and team in The Lancet Oncology, no dose-limiting toxicities or grade 4 or 5 events were observed in the phase Ib trial. The most common grade 3 toxicities were lymphocytopenia and fatigue, each reported in two of the 21 patients.
A post-hoc analysis showed that an objective response was attained by 29% of the trial participants.
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