SAN FRANCISCO—The SFJ Pharmaceuticals Group recently announced that it has enteredinto a collaborative development agreement with Pfizer Inc. to conduct aPhase III clinical trial of Pfizer's investigational pan-HER (pan-humanepidermal 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 withlocally advanced or metastatic non-small cell lung cancer (NSCLC) withactivating mutations of epidermal growth factor receptor (EGFR).
Underthe terms of the agreement, SFJ will provide the funding and clinicaldevelopment supervision to generate the clinical data necessary tosupport a registration dossier on dacomitinib for marketingauthorization by regulatory authorities for the aforementioned indication and, if approved for this indication, SFJ will beeligible to receive milestone payments and earn-out payments.
Thisis the second collaborative agreement between SFJ and Pfizer, with the previous agreement being to conduct a Phase IIItrial in Asia of Pfizer's Inlyta(axitinib) for the adjuvant treatment of patients at high risk ofrecurrent renal cell carcinoma following nephrectomy.
"At SFJ, ourmission is to accelerate the availability of new and innovative drugsinto the world's major markets through co-development," said Robert DeBenedetto,SFJ's president and CEO. "With this important, multinational trial,we are pleased to continue our collaborative relationship with Pfizerand support the clinical development of a promising new agent for thetreatment of lung cancer."
"Pfizer is committed to buildinginnovative partnerships that enable us to advance our clinicaldevelopment programs and deliver new cancer medicines to patients asefficiently as possible around the world," said Garry Nicholson,president and general manager, Pfizer Oncology. "Non-small cell lungcancer remains a difficult disease to treat despite recent advances, andPfizer is evaluating dacomitinib in NSCLC across lines of therapy and arange of histologies and molecular subtypes. By collaborating with SFJon the continued clinical development of dacomitinib in this patientpopulation, we hope to more immediately bring a new first-line therapyto patients in need."
Dacomitinib is an oral, once-daily, smallmolecule inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.It is being evaluated by Pfizer in a comprehensive clinical developmentprogram that includes two global, randomized Phase III clinical trialsinvestigating its safety and efficacy as a second-line and refractorytreatment for NSCLC.