On October 23, 2019 FibroGen, Inc. (NASDAQ: FGEN), reported the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced pancreatic cancer (LAPC) (Press release, FibroGen, OCT 23, 2019, View Source [SID1234542448]).

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"Patients with unresectable locally advanced pancreatic cancer face a dire prognosis. The use of pamrevlumab, a novel anti-fibrotic used as neoadjuvant therapy, may change tumor status from unresectable to resectable thus potentially improving the prognosis of the patient", said Pascal Hammel, MD, PhD a gastroenterologist, oncologist, Hôpital Beaujon, Clichy France. "If this pivotal phase 3 trial is successful, I believe this type of treatment will be highly valued by the physician community treating LAPC."

"With this announcement of dosing of the first patient in our LAPIS study, we are excited to further advance late-stage development of pamrevlumab as a treatment for locally-advanced pancreatic cancer," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, and Drug Safety and Pharmacovigilance, with FibroGen. "We are grateful for the opportunity to build on supportive data from our previous Phase 2 studies, as we continue to explore the potential of pamrevlumab as an important treatment option for patients with LAPC."

In LAPC patients who undergo resection, median survival and five-year survival rates are higher than for unresectable LAPC patients who did not undergo resection. Therefore, achieving surgical resection in this patient population is a meaningful treatment goal.

LAPIS is a multinational randomized, double-blind, placebo-controlled Phase 3 study that will evaluate neoadjuvant pamrevlumab therapy in combination with gemcitabine and nab-paclitaxel. The design of this study is similar to FibroGen’s prior Phase 2 trials. In these studies, a higher percentage of patients treated with the pamrevlumab combination achieved surgical resection and had a statistically significant median survival rate. LAPIS is expected to enroll approximately 260 patients. The primary endpoint of the study is overall survival. The resection rate is a surrogate endpoint, and, should the resection rates favor the pamrevlumab combination, FibroGen plans to request a meeting with the FDA to discuss a marketing application under the provisions of accelerated approval.

For more information regarding this study please visit www.clinicaltrials.gov (NCT03941093).

About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), the patient’s tumor typically involves structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor. Patients with unresectable LAPC have a median survival of 6 to 10 months, only slightly better than patients with metastatic pancreatic cancer, and only 20 percent of newly diagnosed patients are classified as having resectable disease. Patients who have their tumor surgically removed have a much better prognosis with median survival of approximately 23 months with some patients being cured.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and LAPC. Across all clinical studies, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.