BNT113 Clinical Trials
A global randomized Phase 2 trial evaluating BNT113
in combination with pembrolizumab versus pembrolizumab
monotherapy as a first-line treatment in patients with unresectable
recurrent or metastatic HPV16+ HNSCC expressing PD-L1 is ongoing.
Part A is a non-randomized run-in portion (Part A)
designed to demonstrate the safety of the combination
of BNT113 and pembrolizumab.
Part B is randomized and is planned to enroll a total of 267 patients.
Primary endpoints include overall survival and objective response rate.
Secondary endpoints include progression free survival, durable
complete responses, duration of response, patient reported outcomes and
quality of life measures.
In December 2022, we presented preliminary safety data
from Part A of the trial at the ESMO Immuno-Oncology Annual Congress.
The data showed safety was acceptable and in line with the safety profile of BNT113
and pembrolizumab as single agents; no new safety signals were observed
for the combination.
As of July 5, 2022, of 15 treated patients,
12 had completed the safety run-in (pembrolizumab + 4 BNT113 doses).
All patients in the safety run-in had ≥1 AE; the most frequent were pyrexia
(8 patients) and chills (6 patients).
Three patients (25%) that had Grade ≥3 AEs with all classed as SAEs
(pyrexia, hypercalcemia, pleural effusion, shaking/rigors).
In 2/3 patients the AEs (pyrexia, shaking/rigors) were considered related.
No deaths were reported.
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