The SFJ Pharmaceuticals Group (SFJ), a global drug development group of companies, has entered into a collaborative development agreement with Pfizer Inc. 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 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).
Under the terms of the agreement, 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, SFJ's president & CEO. "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."
"Pfizer is committed to building innovative partnerships that enable us to advance our clinical development programs and deliver new cancer medicines to patients as efficiently as possible around the world," said Garry Nicholson, president and general manager, Pfizer Oncology. "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. It is being evaluated by Pfizer in a comprehensive clinical development programme that includes two global, randomized phase III clinical trials investigating its safety and efficacy as a second-line and refractory treatment for NSCLC. Dacomitinib has not been approved by any regulatory agency.
The SFJ Pharmaceuticals Group, is a global drug development group of companies, which provides a unique co-development partnering model for some of the world's top pharmaceutical and biotechnology companies.