The SFJ Pharmaceuticals Group (SFJ), a global drug development group of companies, has entered into a collaborative development agreement with Pfizer to conduct a phase III clinical trial of Pfizer's investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804).
The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).
SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.
This is the second collaborative agreement between SFJ and Pfizer. SFJ previously entered into an agreement with Pfizer to conduct a phase III trial in Asia of Pfizer's Inlyta (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.
"At SFJ, our mission is to accelerate the availability of new and innovative drugs into the world's major markets through co-development," said Robert DeBenedetto, president and CEO of SFJ. "With this important, multi-national trial, we are pleased to continue our collaborative relationship with Pfizer and support the clinical development of a promising new agent for the treatment of lung cancer."
Garry Nicholson, president and general manager, Pfizer Oncology, said, "Non-small cell lung cancer remains a difficult disease to treat despite recent advances, and Pfizer is evaluating dacomitinib in NSCLC across lines of therapy and a range of histologies and molecular subtypes. By collaborating with SFJ on the continued clinical development of dacomitinib in this patient population, we hope to more immediately bring a new first-line therapy to patients in need."
Dacomitinib is an oral, once-daily, small molecule inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.