A clinical trial looking at the efficacy of adding sintilimab to a combination of pemetrexed and platinum met its primary endpoint of improving PFS in patients with first-line advanced or recurrence nonsquamous NSCLC without sensitive EGFR mutation or ALK rearrangement.

The sintilimab injection has already been approved in China for relapsed or refractory classic Hodgkin’s lymphoma after second-line system chemotherapy. The drug works by binding to PD-1 molecules on T-Cells, blocking the PD-1/PD-Ligand 1 pathway, and reactivating T-cells to kill cancer cells. 

The ORIENT-11 trial, is a randomized, double-blind, Phase 3 clinical trial, and is one of 20 involving sintilimab, according to a release from the manufacturer. In this trial, 397 patients were randomized in a 2:1 ratio receiving therapy every three weeks for up to four cycles with one group receiving a placebo instead of the medicine. 

They received the injection and pemetrexed maintenance therapy “until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation.”

Results from the trial are expected to be presented at an “upcoming medical conference,” according to the manufacturer. The companies involved in developing the treatment will also “initiate regulatory discussion” with the National Medical Products Administration “in the near future.” 

Sintilimab injection is not currently approved for use in the US. Further, pemetrexed is not approved to be used in combination with the sintilimab injection in the US.

By Adam Hochron
Source: MD /alert Exclusive