AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) in a subset of patients with small cell lung cancer (SCLC), which accounts for approximately 15% of lung cancer cases.
The phase 3 ADRIATIC trial has been evaluating Imfinzi versus placebo in patients with limited-stage SCLC who had not progressed following concurrent chemoradiotherapy (cCRT).
Limited-stage SCLC accounts for approximately 30% of SCLC diagnoses, with the prognosis for these patients remaining poor despite curative-intent treatment with standard-of-care cCRT.
Results from ADRIATIC showed that Imfinzi demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival and progression-free survival.
The safety profile for Imfinzi was also consistent with its known profile and no new safety signals were identified.
The second arm of the trial testing the efficacy of AZ’s Imjudo (tremelimumab) added to Imfinzi as a secondary endpoint remains blinded and will continue to the next planned analysis, the company said.
“ADRIATIC is the first global phase 3 immunotherapy trial to deliver significant, clinically meaningful improvement in survival in this setting, marking a breakthrough for patients with this devastating disease,” said Suresh Senan, principal investigator in the trial, of the Amsterdam University Medical Center.
Imfinzi is already approved in the EU, US and other countries worldwide to treat extensive-stage SCLC, and AZ has outlined that results from ADRIATIC will be shared with global regulatory authorities.
Susan Galbraith, executive vice president, oncology research and development at AZ, said: “These exciting results build on the transformative efficacy of Imfinzi in extensive-stage SCLC and demonstrate the potential to bring a curative-intent immunotherapy treatment to this earlier-stage setting of SCLC for the first time.”
The readout comes less than a month after AZ announced positive results from a late-stage study evaluating an Imfinzi/Lynparza (olaparib) regimen in patients with advanced or recurrent endometrial cancer.
The phase 3 DUO-E trial had been assessing Imfinzi plus platinum-based chemotherapy, followed by either Imfinzi monotherapy or Imfinzi plus Lynparza as maintenance therapy versus chemotherapy alone.
The company also recently shared promising phase 3 results for Imfinzi in patients with unresectable hepatocellular carcinoma eligible for embolisation.