BioNTech mRNA cancer immunotherapy misses first objective in key study

An article from

Dive Brief:

• An experimental mRNA cancer immunotherapy from BioNTech failed to delay tumor progression in a late-stage study in a form of head and neck cancer, the company said Tuesday.
• According to BioNTech, a combination of its treatment BNT 113 and the widely used drug Keytruda didn’t extend progression-free survival at an interim data check. The trial is testing the dual regimen against Keytruda alone as a first-line treatment in head and neck squamous cell carcinoma that’s driven by a high-risk strain of human papillomavirus. 
• A data monitoring committee encouraged BioNTech to continue the trial to determine whether the BNT 113-Keytruda regimen can meet the study’s other main objective by extending survival. Should it do so, BioNTech could still claim success. The early results “support continued evaluation” and show the drug combination is “engaging its intended therapeutic mechanism,” said co-founder and Chief Medical Officer Özlem Türeci.

Dive Insight:

BioNTech became a household name during the pandemic when it joined with Pfizer to bring to market a COVID-19 vaccine known as Comirnaty. That shot was the first of its kind to win approval, and quickly became one of the most lucrative products in the history of the pharmaceutical industry. 

Comirnaty sales have since fallen significantly amid dwindling demand. The mRNA technology BioNTech is built on has become a political target, too. Those factors have led the company, as well as its peer Moderna, to change course and devote fewer resources to infectious disease research.  

For BioNTech, that strategic pivot has involved going back to its roots in oncology. The German-based company originally aimed to develop cancer treatments when it was formed almost two decades ago and, in the last few years, has made those kinds of therapies the focus of a series of deals. Chief among them was the acquisition of a bispecific cancer treatment it’s now developing through a partnership with Bristol Myers Squibb.

Those investments have produced mixed results so far. That bispecific drug, pumitamig, is now involved in multiple advanced clinical trials. But the company also reported a study setback in colorectal cancer earlier this year, and now a missed study endpoint for a different prospect.  

BioNTech is “leaning ever more” on pumitamig, Leerink Partners analyst Daina Graybosch wrote in August. 

Graybosch added, in that note, that the evidence supporting BNT 113’s activity in head and neck cancer was “sparse” when the Phase 3 study was launched. Her team had been expecting a negative outcome, in part because BioNTech enrolled people with lower levels of the protein PD-L1.

Several drug combinations have also failed over the years to prove more beneficial than treatment with cancer immunotherapies like Keytruda alone.

BioNTech shares fell about 6% in early trading Tuesday.