NO USE OF MAINTENANCE IMMUNOTHERAPY FOR SCLC

Takeaway

Patients with extensive disease small cell lung cancer, who did not progress under first-line chemotherapy, did not profit from maintenance immunotherapy with either nivolumab alone or nivolumab plus ipilimumab. They also had high discontinuation rates and possibly higher mortality.

Why this matters

While first-line platinum-based chemotherapy yields high response rates in extensive disease small cell lung cancer (ED-SCLC), these responses lack duration. The CheckMate 451 study aimed to improve survival by giving maintenance immunotherapy directly after successful chemotherapy.

Study design

834 patients who did not progress after 4 cycles of chemotherapy were randomized to either combination therapy with nivolumab and ipilimumab, or nivolumab alone, or placebo. Treatment was for 2 years or until progression, death, or unacceptable toxicity.

Key results

• As has been reported previously, the primary endpoint of overall survival was not prolonged significantly under the combination therapy or with nivolumab alone.
• Study author Taofeek Owonikoko (Atlanta), presenting late-breaking results, saw, "some indication that compared to placebo, it took longer for the cancer to progress in patients who received either combination immunotherapy or nivolumab alone."
• Adverse event rates were 86% with combination immunotherapy, 61% with nivolumab alone, and 50% with placebo. Discontinuation rates were 31%, 9%, and less than 1% respectively. 7 patients died on combination therapy and one each on nivolumab and placebo.

Expert statement

“This appears to be the end of the story for maintenance immunotherapy in unselected SCLC patients,” Dr Pilar Garrido, Head of the Thoracic Tumour Section, Medical Oncology Department, Ramón y Cajal University Hospital, Madrid, Spain.