Merck and Pfizer announced the discontinuation of the phase 3 JAVELIN Ovarian PARP 100 study that was comparing the safety and efficacy of avelumab plus chemotherapy followed by avelumab plus talazoparib (Talzenna) vs an active comparator in treatment-naive patients with locally advanced or metastatic ovarian cancer (stage III or IV).
JAVELIN Ovarian PARP 100 (NCT03642132) was an open-label, international, multi-center, randomized study that evaluated avelumab as part of combination therapy in stage III or IV ovarian cancer. The primary endpoint was progression-free survival (PFS) as determined by a blinded independent central review (BICR) assessment per RECIST v1.1.
The decision to halt the trial was due to the fact that the benefit associated with avelumab for frontline ovarian cancer does not support continuing the trial in an unselected patient population. Other determinants include the “rapidly changing treatment landscape”, the approval of a PARP inhibitor for use in a maintenance setting, as well as the previously announced interim results from JAVELIN Ovarian 100. The Companies stated that the decision to stop the JAVELIN trial was not due to safety reasons.
Avelumab (Bavencio), a human anti-programmed death ligand-1 (PD-L1) antibody, is currently approved to treat patients with metastatic Merkel cell carcinoma (mMCC) and patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It works by releasing the suppression of the T-cell mediated antitumor immune response in preclinical models, and by inducing NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
The JAVELIN clinical development program includes at least 30 programs and over 9000 evaluated patients for >15 tumor types.