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Duvelisib

Generic Name
Duvelisib
Brand Names
Copiktra
Drug Type
Small Molecule
Chemical Formula
C22H17ClN6O
CAS Number
1201438-56-3
Unique Ingredient Identifier
610V23S0JI
Background

Duvelisib, also known as IPI-145 and INK-1197, is a small-molecule inhibitor of phosphoinositide-3 kinases that was designed initially to prove that simultaneous inhibition of the isoforms delta and gamma can produce a broad adaptative and innate immune cell inhibitory activity. All the work around duvelisib showed that this agent is a potent inhibitor of both forms. Duvelisib was developed by Verastem, Inc and FDA approved on September 24, 2018.

Indication

Duvelisib is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have trialed at least two prior therapies.

Associated Conditions
Refractory Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia (CLL), Relapsed Small Lymphocytic Lymphoma

Phase 3 TERZO Trial to Evaluate Duvelisib in Rare T-Cell Lymphoma Following Promising Phase 2 Results

• The upcoming TERZO trial will assess duvelisib against standard chemotherapy in patients with nodal T-cell lymphoma with follicular helper T phenotype, addressing a significant treatment gap in rare lymphomas. • Phase 2 PRIMO study demonstrated promising results with duvelisib showing a 48% overall response rate and 33.3% complete response rate in relapsed/refractory PTCL patients. • The TERZO trial aims to enroll 124 patients across EU and UK, with progression-free survival as the primary endpoint, potentially leading to regulatory approval if successful.

Lilly to Acquire Scorpion Therapeutics' Mutant-Selective PI3Kα Inhibitor Program for $2.5 Billion

• Eli Lilly is set to acquire Scorpion Therapeutics' PI3Kα inhibitor program, including STX-478, currently in Phase I/II trials, for up to $2.5 billion. • STX-478 is a novel, oral, mutant-selective PI3Kα inhibitor targeting breast cancer and advanced solid tumors, potentially offering improved tolerability. • The acquisition expands Lilly's oncology pipeline, aiming to address the unmet need for effective and safe treatments for hormone-positive breast cancers with PI3Kα mutations. • Scorpion Therapeutics will spin out a new entity focusing on precision medicines, with Lilly retaining a minority equity interest in the new company.

Duvelisib Shows Promise in Relapsed/Refractory Peripheral T-Cell Lymphoma

• Phase 2 PRIMO trial data showed duvelisib achieved a 48% overall response rate and a 33% complete response rate in R/R PTCL patients. • AITL subgroup analysis revealed a 62% ORR and 51% CR, suggesting enhanced efficacy in T-follicular helper cell lymphoma. • Secura Bio plans to initiate a Phase 3 trial (TERZO) to evaluate duvelisib in R/R nodal T-follicular helper cell lymphoma. • The safety profile of duvelisib in the PRIMO trial was consistent with previous studies, with manageable adverse events.

Venetoclax Enhances CAR T-Cell Therapy Response in Chronic Lymphocytic Leukemia

• Roswell Park Comprehensive Cancer Center research elucidates how venetoclax synergizes with CAR T-cell therapy to combat chronic lymphocytic leukemia (CLL). • Venetoclax strengthens cancer-killing T lymphocytes, improving their function and fitness when combined with CAR T-cell therapy. • The study involved multiomic analysis of blood samples from 14 CLL patients, revealing specific changes in immune cells after venetoclax treatment. • Findings suggest venetoclax could repair the immune system in CLL patients, potentially leading to more effective combination treatments.
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