Policy & Regulation
National Comprehensive Cancer Network Adds Verastem Oncology's Copiktra Capsules to Clinical Practice Guidelines in Oncology for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
10 October 2018 - - US-based The National Comprehensive Cancer Network (NCCN) has added Copiktra (duvelisib) capsules to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), US-based biopharmaceutical company Verastem, Inc. (NASDAQ: VSTM) said.

Copiktra is an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

The US Food and Drug Administration granted approval to Copiktra on September 24, 2018, for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies.

Based on efficacy and safety data from patients with at least two prior lines of therapy who were treated in the randomised, Phase 3 DUO trial (NCT02004522), the NCCN Guidelines now include a Category 2A recommendation for use of Copiktra for adult patients whose disease is relapsed or refractory after treatment with at least two prior therapies.

The Category 2A recommendation indicates that based upon lower-level evidence, there is uniform NCCN consensus that Copiktra is appropriate for these patients.

A randomised, multicenter, open-label trial (DUO; NCT02004522) compared COPIKTRA versus ofatumumab in 319 adult patients with CLL (N = 312) or SLL (N = 7) after at least one prior therapy. The study randomized patients with a 1: 1 ratio to receive either Copiktra 25mg BID until disease progression or unacceptable toxicity, or ofatumumab for 7 cycles.

The approval of Copiktra was based on efficacy and safety analysis of patients with at least 2 prior lines of therapy, where the benefit: risk appeared greater in this more heavily pretreated population compared to the overall trial population.

In this subset (95 randomized to Copiktra, 101 to ofatumumab), the median patient age was 69 years (range: 40 to 90 years), 59% were male, and 88% had an ECOG performance status of 0 or 1. Forty-six % received 2 prior lines of therapy, and 54% received 3 or more prior lines.

At baseline, 52% of patients had at least one tumor ≥ 5 cm, and 22% of patients had a documented 17p deletion.

During randomised treatment, the median duration of exposure to Copiktra was 13 months (range: 0.2 to 37), with 80% of patients receiving at least 6 months and 52% receiving at least 12 months of Copiktra. The median duration of exposure to ofatumumab was 5 months (range: < 0.1 to 6).

Efficacy was based on progression-free survival as assessed by an Independent Review Committee. Other efficacy measures included overall response rate. Efficacy of Copiktra compared to ofatumumab specifically in patients treated with at least two prior therapies is below.

Abbreviations: CR = complete response; IRC = Independent Review Committee; PFS = progression-free survival; PR = partial response; SE = standard error

Verastem Oncology is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer.

Its first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin's lymphoma. The company's pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment.
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