SECURA BIO ANNOUNCES THE PRESENTATION OF NEW COPIKTRA® (duvelisib) DATA FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMAS (PTCL).

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Dec 14, 2021, 09:00 ET

SUMMERLIN, Nev., Dec. 14, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that new data for the treatment of relapsed or refractory(r/r) PTCL patients with COPIKTRA were presented at the 63^rd annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.

Jonathan Brammer M.D. of The Ohio State University James Comprehensive Cancer Center presented the interim analysis of the phase 2 PRIMO trial of r/r PTCL patients treated with single-agent COPIKTRA 75mg BID for the first two months followed by 25mg BID until progression or unacceptable toxicity. 78 of a planned 125 patients were included in this analysis with a minimum follow-up of 6 months. The trial is ongoing, with completion expected in 2022.

The interim results include an ORR by IRC assessment of 50% (39/78 pts) and a CR of 32.1% (25/78) with a median duration of response of 233 days (range, 1-420+). Patients had a median of 3 (range, 1-7) prior therapeutic regimens and included the following PTCL subtypes: PTCL NOS (53.8%), ALCL (14.1%), AITL (26.0%) and Other (0.5%). 18% of patients remain on therapy, 47.4% discontinued due to PD, 6.4% discontinued for stem cell transplant, and 19.2% discontinued due to unacceptable toxicity.

Overall, the safety profile was consistent with previous studies; in this analysis the most frequent > Grade 3 adverse events seen were neutropenia (38.5%), ALT/AST increased (24.4%/ 21.8%), rash (7.7%), lymphocyte count decreased (7.7%), and sepsis (6.4%). ALT and/or AST elevations were the most common AEs leading to treatment discontinuations (N=12, 15.4%).

"Patients with r/r PTCL usually relapse quickly and have limited treatment options, and the data from the PRIMO trial show very promising activity and even a remarkable number of complete responses. Importantly, these responses are better than current standard of care options" said Dr. Brammer.

"We are encouraged to see such robust responses in a significant number of patients who are suffering with these aggressive forms of lymphoma" said David Cohan M.D., Chief Medical Officer at Secura Bio. "We will continue to develop COPIKTRA for the treatment of the r/r population, and we have also expanded our clinical research program to include earlier lines of therapy for various T-cell lymphomas."

The original abstract published for ASH can be viewed by clicking HERE.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.

INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Please click here to see full U.S. Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Secura Bio at 1-800-9SECURA (1-844-973-2872).

About Secura Bio, Inc.

Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit www.securabio.com