AstraZeneca pulls PD-L1 combo test, RSV candidate

AstraZeneca has dropped a late-stage combo treatment of PD-L1 candidate durvalumab and CTLA-4 med tremelimumab in first-line metastatic pancreatic ductal carcinoma.

It’s the fourth-quarter clear out, and AstraZeneca has pulled the plug on a combo of its immuno-oncology candidate as well as axing a test of its biologic arm’s RSV drug as it sheds some more light on its birds of prey-themed tests in head and neck cancers.

In the “removed from phase 3” box coming out of its morning presentations on Thursday, Feb. 2, it said it has dropped a late-stage combo treatment of PD-L1 candidate durvalumab and CTLA-4 med tremelimumab (which has seen its own trial setbacks) in first-line metastatic pancreatic ductal carcinoma (the Alps study).

This also comes after its recent decision to change up its timings on a study of durvalumab in squamous cell head and neck cancers (HNSCC).

The Big Pharma confirmed to me: “With recent changes in the HNSCC competitive landscape, including the approval in the U.S. for PD-1 monotherapies for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, and based on [overall survival] data in all-comer patients, we will not make a regulatory submission for accelerated approval based on the single-arm phase 2 Hawk trial in PD-L1 high patients and the uncontrolled randomised or the phase 2 Condor trial (in PD-L1 low/neg patients).”

The company said it “remains committed” to developing durvalumab both on its own and in combo with tremelimumab for patients with recurrent metastatic HNSCC: “Through the delivery of the phase 3 randomized controlled clinical Eagle trial (in second-line HNSCC) with data expected in 2018, and the phase 3 randomized controlled clinical Kestrel trial (in first-line HNSCC) with data expected in H2 2017.” Both studies are enrolling all-comer patients, the company added.

Moving further back down the pipeline, four NME phase 2 meds have also been axed and divested, including its outlicensing of GI candidate MEDI2070 to Allergan a few months back, with MEDI7510 also now in limbo. 

This candidate is a respiratory syncytial virus (RSV) sF antigen plus GLA and works as a synthetic molecule licensed from Immune Design’s GLAAS discovery platform, and was being studied by MedImmune, AstraZeneca’s biologics arm.

A spokesperson for the company tells FierceBiotech: “Based on the initial efficacy results from the phase 2b study, we decided not to proceed with the second-year safety and immunogenicity follow-up phase of the MEDI7510 study. We are currently conducting a full and thorough evaluation of the phase 2b results to determine next steps.”

RSV candidates have had a tough time of late, and just this week Aviragen said its BTA585 drug failed to have any impact on viral load in around 20 adult patients given an intranasal inoculation with the virus, the most common cause of acute lower respiratory tract infection in children.

Back in September, Novavax also saw its shares plummet when it announced that a late-stage test of its RSV vax had missed all of its marks across a 12,000-strong study.

And AstraZeneca/MedImmune have had setbacks here too: Back in 2010, the Big Pharma wrote off its big motavizumab program for RSV after it failed to make the grade. Motavizumab was intended to replace the blockbuster RSV drug Synagis.

And even further back in phase 1, the U.K.-headquartered Big Pharma said it had divested its NDMA suicidal ideation drug AZD8108.

Editor's note: This article has been corrected to show that the RSV drug MEDI7510 had not been fast-tracked at the FDA, and that the PD-L1 combo had not entered into phase 3.