— 5F9 Well-Tolerated in Combination with Rituximab —
— Durable Responses Observed in DLBCL and Indolent Lymphoma; Median Duration of Response Not Yet Reached —
— Overall Response Rate (ORR) of 36% Observed in DLBCL and ORR of 61% Observed in Indolent Lymphoma —
— FDA Feedback Suggests Single-Arm Pivotal Trial May Support Registration of 5F9 in Combination with Rituximab in Heavily Pre-Treated DLBCL Patients, Including Those Ineligible for CAR-T Therapy —
— Forty Seven to Host Conference Call and Webcast at 8:00 am ET on Monday, June 17, 2019 —
— Durable Responses Observed in DLBCL and Indolent Lymphoma; Median Duration of Response Not Yet Reached —
— Overall Response Rate (ORR) of 36% Observed in DLBCL and ORR of 61% Observed in Indolent Lymphoma —
— FDA Feedback Suggests Single-Arm Pivotal Trial May Support Registration of 5F9 in Combination with Rituximab in Heavily Pre-Treated DLBCL Patients, Including Those Ineligible for CAR-T Therapy —
— Forty Seven to Host Conference Call and Webcast at 8:00 am ET on Monday, June 17, 2019 —
Forty Seven, Inc., a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced updated data from its ongoing Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab for the treatment of relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL), including diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma. The data will be presented in an oral session at the 24th Congress of the European Hematology Association (EHA) in Amsterdam, Netherlands. Also at EHA, Forty Seven will present data from its ongoing Phase 1b clinical trial evaluating 5F9 as a monotherapy and in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which were previously presented at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting.
“Despite advancements in the treatment of newly-diagnosed NHL, there are very limited options for patients with advanced forms of the disease, who have failed multiple lines of treatment or are ineligible for existing therapies due to advanced age, numerous co-morbidities, and/or the diagnosis of aggressive, proliferating disease,” said Justin Kline, M.D., University of Chicago, Department of Medicine, an investigator for the clinical trial. “In treating these patients, our goal is to achieve durable responses and stave off the rapid disease progression that can limit overall survival to a matter of months. As such, I am encouraged by the updated data for 5F9 in combination with rituximab, which showed consistent clinical benefit across a range of patient populations — including patients who are heavily pre-treated, ineligible for CAR-T therapy or suffering from primary refractory disease — as well as durable responses in both DLBCL and FL. I am eager to continue evaluating this combination as a well-tolerated, chemotherapy-free regimen, with the potential to induce long-term remissions even in the sickest patients.”
“Today’s announcement marks a significant milestone in our development of 5F9 for the treatment of r/r NHL,” said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of Forty Seven, Inc. “The design of our Phase 1b/2 clinical trial allowed us to continue to explore the clinical benefit of 5F9 in combination with rituximab in patients with DLBCL and indolent lymphoma, while also expanding into a subset of older, sicker DLBCL patients who have been deemed ineligible for CAR-T therapy. We are particularly gratified to see meaningful activity in this newly-defined population, which has never before been evaluated in clinical trials, and for whom there are few, if any, effective treatment options available. Importantly, following recent interactions with the U.S. Food and Drug Administration (FDA), we believe we may be able to pursue approval in a heavily pre-treated population, including DLBCL patients who have failed at least two prior lines of therapy or who are ineligible for CAR-T therapy, with a single-arm pivotal study serving as the basis for our BLA filing. These developments bring us closer to achieving our vision of establishing 5F9 as a cornerstone immunotherapy for the treatment of a broad range of cancers.”
Investor Conference Call and Webcast Information
Forty Seven will host a live conference call and webcast on Monday, June 17, 2019 at 8:00 a.m. ET to review the clinical data presented at EHA. The conference call may be accessed by (866) 953-0780 (domestic) or (630) 652-5854 (international), and by referring to conference ID 3236239. A webcast of the conference call will also be in the Investors section of the Forty Seven website at www.fortyseveninc.com. The archived webcast will be available approximately two hours after the conference call and will be available for 30 days following the call.
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