Data from the Phase 2 PRIMO trial in 123 patients showed an overall response rate (ORR) of 48%, a complete response (CR) rate of 33%, and a median duration of response (DOR) of 7.89 months The Company also presented its design for a phase 3 randomized clinical trial of duvelisib in relapsed/refractory (R/R) nodal T-follicular helper cell lymphoma SUMMERLIN, Nev., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (Secura Bio), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today presented two posters at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego, CA. The first poster highlighted new data from the Company’s phase 2 PRIMO trial of duvelisib in the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL); the second poster highlighted the clinical design for the Company’s planned phase 3 randomized clinical trial of duvelisib in R/R nodal T-follicular helper cell lymphoma (TERZO™). The first poster, entitled: Duvelisib in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma: Final Results from the Phase 2 PRIMO Trial was presented by Dr. Neha Mehta-Shah, Washington University School of Medicine, and highlighted the outcomes of 123 patients in the dose expansion phase of the PRIMO Phase 2 clinical trial, an open-label, single-arm trial investigating the safety and efficacy of duvelisib monotherapy in R/R PTCL patients from the U.S., EU, UK and Japan. Results from the expansion arm demonstrated an overall response rate (ORR) of 48%, a complete response (CR) rate of 33%, and a median duration of response (DOR) of 7.89 months. Adverse events were consistent with those observed in previous studies of duvelisib and were generally manageable with per-protocol dose modifications. Of note, a subgroup of 37 patients with angioimmunoblastic T-cell lymphoma (AITL) demonstrated an ORR of 62%, CR of 51%, median PFS 8.34 months, and median overall survival (OS) 18.07 months. “Patients with R/R PTCL usually relapse quickly and have limited treatment options. The PRIMO data show very promising activity, particularly in the AITL subgroup. Importantly, these observed responses support duvelisib as a promising potential agent for this disease,” said Dr. Neha Mehta-Shah, Assistant Professor of Medicine at Washington University in St. Louis. Based on these results, Secura Bio is planning to initiate a randomized phase 3 clinical trial to evaluate duvelisib in R/R nodal T-follicular helper cell lymphoma in the European Union and the United Kingdom (TERZO: NCT06522737; EU CT: 2024-516605-23-00). The Company highlighted the trial design in a second poster entitled: “A Multicenter, Open-label, Phase 3, Randomized Controlled Trial of Duvelisib versus Investigator’s Choice of Gemcitabine or Bendamustine in Patients with Relapsed/Refractory Nodal T-cell Lymphoma with T- Follicular Helper Phenotype,” and anticipates enrolling its first patient in the phase 3 trial in the first half of 2025. The T-follicular helper (TFH) cell is the cell of origin in AITL. Lymphomas with a TFH cell of origin (including AITL) have similar genetic profiles and have been classified under the category of nodal TFH cell lymphomas. The outcomes of the AITL subgroup of PRIMO showed greater activity in patients who had R/R nodal T-cell lymphoma with TFH phenotype. Chip Romp, Chief Executive Officer of Secura Bio added, “We are encouraged by the robust results of the PRIMO trial in R/R PTCL, a devastating disease with a high unmet medical need, a poor prognosis, and limited effective treatment options. We are very enthusiastic about the data from the AITL subgroup, and we look forward to continuing development of this therapy and the initiation of the phase 3 TERZO trial in the coming weeks.” The PRIMO phase 2 clinical trial was a global, multicenter, open-label, parallel cohort study evaluating duvelisib for the treatment of adult patients with R/R PTCL. The expansion group of 123 patients was added to the trial based on previously announced results from the dose optimization phase. In this expansion phase, duvelisib was dosed at 75 mg twice daily for two 28-day cycles, followed by 25 mg twice daily, until progressive disease or unacceptable toxicity. Patients in the study had a median (range) of 2 (1-9) prior therapies and included the following histologies: 43.1% PTCL-not otherwise specified (PTCL-NOS), 30.1% AITL, and 16.3% anaplastic large-cell lymphoma (ALCL). The median age was 65 years. Outcomes for the 123 patients included an ORR of 48% (59/123), with a CR rate of 33.3% (41/123). ORRs by baseline histology were 62.2% (AITL), 49.1% (PTCL-NOS), and 15.0% (ALCL). The median progression-free survival (PFS) by Independent Review Committee was 3.45 months with a median PFS by baseline histology of 8.34 months (AITL), 3.45 months (PTCL-NOS), and 1.64 months (ALCL). Median OS was 12.35 months. Nineteen (15%) patients went on to receive stem cell transplant (SCT) at the time of treatment discontinuation (11 of 12 had a planned SCT, and 8 additional patients received unplanned SCT). The safety profile seen in PRIMO was consistent with that seen in previous duvelisib studies, and adverse events were generally manageable with per-protocol dose modifications. The most frequently occurring all-causality grade ≥3 treatment-emergent adverse events in ≥5% of patients were alanine aminotransferase elevation (21.1%), decreased neutrophil count (17.9%), aspartate aminotransferase elevation (17.1%), and diarrhea (9.8%). About Peripheral T-cell LymphomaPeripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. About COPIKTRA (duvelisib)COPIKTRA (duvelisib) 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. INDICATIONS AND USAGECOPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is indicated in the European Union for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia after at least two prior therapies, and for follicular lymphoma that is refractory to at least two prior systemic therapies. COPIKTRA has been given Fast Track status in the United States for the treatment of adult patients with PTCL who have received at least one prior therapy. ORPHAN DRUG DESIGNATIONSThe United States FDA has issued an Orphan Drug Designation to COPIKTRA as a treatment for patients with T-cell lymphoma. The European Commission has issued an Orphan Drug Designation to COPIKTRA for the treatment of adult patients with PTCL. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. 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 https://copiktra.com/. Information about duvelisib clinical trials can be found on https://www.clinicaltrials.gov/. IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITISSee full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patientsFatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspectedFatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRAFatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRAFatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic functionNeutropenia: Monitor blood countsEmbryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential 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 CYP3A4 inhibitors: Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitorsStrong CYP3A4 inducers: Avoid coadministrationModerate CYP3A4 inducers: Avoid coadministration. If coadministration cannot be avoided, increase the dose of COPIKTRACYP3A4 substrates: Monitor for signs of toxicities when coadministering 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 https://www.securabio.com/. Investor & Media ContactWill BrownChief Financial OfficerPhone: 619-986-1364ir@securabio.com
