AstraZeneca has enlisted the aid of Incyte to try to boost its ambitions in a category of lung cancer immunotherapy where it has a lead over competitors.
The two companies have agreed to pair Incyte’s IDO inhibitor epacadostat with AZ’s PD-L1 inhibitor Imfinzi in a phase 3 trial—due to get underway next year—as a second-line treatment for patients with locally advanced non-small cell lung cancer (NSCLC) that isn’t treatable with surgery and whose disease has not progressed following platinum-based chemoradiation therapy. The phase 3 trial, which will be co-funded by the two companies and carried out by AZ, is expected to start enrolling patients in the first half of 2018, say the partners.
Incyte is among the leaders in the race to bring an IDO1-targeted immuno-oncology drug to market and is already working with AZ on cancer immunotherapy, having signed an agreement in 2014 to study the two drugs in a phase 1/2 study, as well as with just about every other commercial player in immuno-oncology.
IDO1 inhibitors are thought to reverse localized tumor-associated immune suppression and restore the ability of immune cells to combat malignant cells, working in a different way to current checkpoint inhibitors, which block the signals that help tumors avoid detection by the immune system.
The biotech is certainly spreading the net wide when it comes to partnering epacadostat. It has a wide-ranging agreement with Merck & Co. and reported encouraging data at this year’s ASCO meeting in Chicago from a midstage trial of epacadostat alongside Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in several solid tumors. That pairing is already in phase 3 testing for five tumor types, including NSCLC.
Incyte is also working with Bristol-Myers Squibb, signing a deal earlier this year to test epacadostat in combination with Opdivo (nivolumab) in two phase 3 NSCLC trials, as well as with Roche on Tecentriq (atezolizumab) combo studies. The collaboration with BMS has however been put under strain by a legal spat over intellectual property for BMS’ in-house IDO drug.
AZ is also not being faithful, as last month it reached a deal with NewLink Genetics to study its IDO pathway inhibitor with Imfinzi in pancreatic cancer. The promiscuity is further evidence of the frantic dealmaking going on as I-O players try to keep pace with their rivals and spread the betting on effective combination therapies.
The patient population covered by its latest deal with AZ is thought to be critical for the U.K. big pharma company’s prospects with Imfinzi. It is the first and, so far, the only checkpoint inhibitor to show a benefit in this group, showing its worth in the PACIFIC trial which led to a filing in Europe.
The data gave some succor to AZ after the failure of Imfinzi and its CTLA4 inhibitor tremelimumab to hit the mark in the phase 3 MYSTIC trial, and analysts have suggested it could make up to $1.75 billion in sales from this indication alone.