Forty Seven, Inc. Announces Updated Data from Phase 1b/2 Clinical Trial of 5F9 in Combination with Rituximab in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma
-- 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
“Despite advancements in the treatment of newly-diagnosed
“Today’s announcement marks a significant milestone in our development of 5F9 for the treatment of r/r NHL,” said
Data from the Ongoing Phase 1b/2 Clinical Trial in r/r
Forty Seven’s Phase 1b/2 trial, which is being funded in part by the
As of the data cutoff of
As of the data cutoff, 5F9 was well-tolerated in combination with rituximab. Adverse events (AEs) were consistent with prior clinical experience. Most AEs were Grade 1 or Grade 2, and the most commonly-reported AEs were expected CD47-mechanism-based effects on red blood cells, which led to a temporary and reversible anemia, and infusion-site reactions. No autoimmune-related AEs were observed, nor were any significant late safety signals observed in patients treated with 5F9 for up to 24 months. No maximum tolerated dose was reached with up to 45 mg/kg of 5F9 dosing. Eight out of 115 patients discontinued treatment due to an AE (7%).
Clinical Activity Data
As of the data cutoff, 97 patients were evaluable for response assessment, including 21 relapsed/refractory DLBCL patients who were treated in the Phase 1b portion of the study, 38 DLBCL patients who were treated in the Phase 2 portion of the study and 38 indolent lymphoma patients (35 patients with FL and three patients with MZL).
|Best Overall Response||Phase 1b
N = 21 (%)
N = 38 (%)
|≥ 3 Prior Lines of Therapy
N = 39 (%)
|Primary refractory disease or
relapsed/refractory to ≥ 2 prior
lines of therapy
relapsed/refractory to ≥ 2
prior lines of therapy and
ineligible for CAR-T
|Subgroup analysis of
combined Phase 1b and
Phase 2 Data
|ORR||10 (48)||11 (29)||15 (38)|
|CR||7 (33)||2 (5)||7 (18)|
|PR||3 (14)||9 (24)||8 (20)|
|SD||4 (19)||3 (8)||4 (10)|
Among patients treated in the Phase 1b portion of the trial, the median duration of response has not been reached, with a median follow-up of over 13.8 months. This includes one patient who has remained in a durable complete response (CR) for more than 24 months.
|Phase 1b + 2
FL N = 35; MZL N = 3 (%)
|Relapsed/refractory to ≥ 2 prior lines of therapy|
Among patients treated in the Phase 1b portion of the trial, the median duration of response has not been reached with a median follow-up of over 21 months. This includes the patient who has remained in a durable CR for more than 28 months.
Additionally, 5F9 tumor penetrance was evaluated at 30 and 45 mg/kg as a key pharmacodynamic endpoint. Data show that the 30 mg/kg maintenance dose of 5F9 saturated the tumor microenvironment similarly to 45 mg/kg, with similar efficacy. As a result, a 30 mg/kg maintenance dose of 5F9 was selected as the recommended dose for use in future clinical studies.
Clinical Development Plans for 5F9 in r/r
Based on feedback from a Type C meeting with the
In parallel, the Company will continue ongoing efforts to evaluate 5F9 as part of additional combination regimens for patients with DLBCL, including in patients in earlier lines of treatment. This includes the planned triplet regimen of 5F9, rituximab and atezolizumab, which Forty Seven is evaluating in collaboration with Genentech, and the planned triplet regimen of 5F9, rituximab and acalabrutinib, which Forty Seven is evaluating in collaboration with Acerta Pharma, in addition to potential studies of 5F9 in combination with other targeted antibodies.
Forty Seven will also evaluate opportunities to advance 5F9 in combination with rituximab for patients with indolent lymphoma.
Data from the Ongoing Phase 1b Clinical Trial in MDS and AML
As Forty Seven previously presented at the 2019 ASCO Annual Meeting in
Based on the favorable safety profile and encouraging clinical activity observed in this Phase 1b clinical trial, expansion cohorts have been initiated in patients with both higher-risk MDS and untreated AML with 5F9 in combination with azacitidine. In addition, based on feedback from a Type B meeting with the
Investor Conference Call and Webcast Information
Forty Seven will host a live conference call and webcast on
5F9 is a monoclonal antibody against CD47 that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, thus blocking the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," “potential,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the overall advancement of 5F9 in clinical trials; the potential of 5F9 as a monotherapy and in combination with azacitidine for the treatment of MDS and AML; the potential of 5F9 as a tolerable treatment option for patients with MDS and AML as a monotherapy and in combination; the sufficiency of the Company’s single arm pivotal trial design and results from such trial for
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven's stock price. Additional information concerning these and other risk factors affecting Forty Seven's business can be found in Forty Seven's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Forty Seven disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
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Source: Forty Seven, Inc.