BioNTech mRNA cancer shot misses first goal in head and neck trial
An experimental mRNA cancer treatment from BioNTech failed to slow tumor growth in a key head and neck cancer trial, BioPharma Dive and Reuters reported. The trial will go on to test whether the treatment helps patients live longer. BioNTech shares fell about 6% in early trading on Tuesday, BioPharma Dive reported.
An experimental mRNA cancer immunotherapy from BioNTech missed the first of two main goals in a head and neck cancer trial, BioPharma Dive and Reuters reported.
The trial tested BioNTech's BNT113 together with Merck's drug Keytruda in patients with head and neck squamous cell carcinoma linked to the HPV16 virus, Reuters reported. The combination did not show a statistically significant improvement in progression-free survival compared with Keytruda alone. Progression-free survival measures how long a patient lives without the disease getting worse.
An independent data monitoring committee recommended that the study continue, Reuters reported. It will now test the trial's second main goal, overall survival, to see whether the treatment helps patients live longer. If it does, BioNTech could still claim success, BioPharma Dive reported.
"While the PFS result was not statistically significant at this first analysis, the data support continued evaluation of BNT113 plus pembrolizumab in this trial and show that it is engaging its intended therapeutic mechanism," said Özlem Türeci, BioNTech's chief medical officer, Reuters reported. Pembrolizumab is Keytruda's chemical name.
"While disappointing, HNSCC is heterogeneous and heavily immunosuppressed, making incremental efficacy over pembrolizumab challenging despite the HPV16 target," said Citi analyst Geoffrey Meacham, Reuters reported.
Leerink Partners analyst Daina Graybosch wrote in August that the evidence for the drug in head and neck cancer was "sparse" when the late-stage study began, BioPharma Dive reported. Her team had expected a negative result.
BioNTech became widely known for its COVID-19 vaccine made with Pfizer, BioPharma Dive reported. As sales of that shot fell, the German company shifted back toward cancer research. It also reported a study setback in colorectal cancer earlier this year, BioPharma Dive said.
BioNTech shares fell about 6% in early trading Tuesday, BioPharma Dive reported. Reuters said its U.S.-listed shares were down nearly 6% before the market opened.
What we know: BNT113 plus Keytruda did not delay tumor growth at the first analysis, and the trial continues.
What we don't: Whether the combination will help patients live longer when overall survival data come in.
Where outlets agree BioPharma Dive and Reuters both report that BNT113 plus Keytruda missed the progression-free survival goal and that the trial will continue to test survival.
Where they differ The outlets cited here report the same key facts so far.