AstraZeneca reports positive results for phase 2 COAST trial of oleclumab and monalizumab

AstraZeneca has reported positive results from the COAST phase 2 trial of its oleclumab or monalizumab in combination with Imfinzi (durvalumab) in patients with non-small cell lung cancer (NSCLC).

The pharma giant said that the mid-stage clinical trial showed the experimental combinations to have improved progression-free survival (PFS) as well as objective response rate (ORR). This was in comparison to Imfinzi alone in 189 patients with unresectable, stage 3 NSCLC, who had not progressed following concurrent chemoradiation therapy (CRT).

While oleclumab is an anti-CD73 monoclonal antibody, monalizumab is an anti-NKG2A monoclonal antibody. Imfinzi is AstraZeneca’s lung cancer drug.

Roy S. Herbst — Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and Chair of the COAST Steering Committee said: “Imfinzi is the established standard of care for patients with unresectable, Stage III NSCLC, but solutions are still needed for patients who do not benefit from currently available therapies.

“The remarkable improvement observed with the addition of oleclumab or monalizumab to Imfinzi, along with the strong safety profile, suggests these novel combinations could further redefine outcomes for these patients.”

AstraZeneca said that following a median follow-up of 11.5 months, the results of an interim analysis showed the Imfinzi, oleclumab combo to have cut down the risk of disease progression or death by 56%.

On the other hand, the combination of Imfinzi and monalizumab reduced the risk of disease progression by 35%.

According to AstraZeneca, the 10-month PFS rate for the durvalumab plus oleclumab combination was 64.8% and for durvalumab plus monalizumab was 72.7%. This was in comparison to 39.2% PFS rate with durvalumab alone.

There was also an increase in the primary endpoint of confirmed ORR for the Imfinzi, oleclumab combination compared to Imfinzi alone (30% vs. 18%) and for Imfinzi plus monalizumab over Imfinzi alone, which is 36% vs. 18%.

Susan Galbraith — Executive Vice President of AstraZeneca Oncology R&D said: “Imfinzi has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity.

“Based on the stand-out results from COAST, we plan to start a registrational trial with the hope of bringing these new treatment options to patients that further increase the potential for cure in this setting.”