Positive Opinion on Lymphoma Drug Highlights Week in Cancer News
Top news of the week in oncology and cancer drug development.
Custirsen Combo Misses OS Goal in Phase III NSCLC Trial
The combination of custirsen with docetaxel failed to significantly extend overall survival compared with docetaxel alone as a second-line treatment for patients with non—small cell lung cancer, according to top-line results from the phase III ENSPIRIT study. At the time of the interim analysis, the ENSPIRIT trial had randomized 664 patients with stage IV NSCLC to receive second-line treatment with docetaxel alone or in combination with custirsen.
The median OS was 9.0 months with the addition of custirsen versus 7.9 months with docetaxel alone (HR, 0.915; P = .178). Findings from the ENSPIRIT trial join other disappointing results for custirsen, which were reported earlier this year and in 2014. In the phase III SYNERGY trial, reported in 2014, the addition of custirsen to docetaxel and prednisone failed to improve OS compared with chemotherapy/prednisone for men with metastatic castration-resistant prostate cancer.
A similar lack of efficacy was seen with the combination of custirsen and cabazitaxel for men with pretreated mCRPC in the phase III AFFINITY trial, which was recently reported at the 2016 ESMO Annual Meeting. At this time, there are no other registered trials exploring custirsen.
CHMP Issues Positive Opinion for Nivolumab in Hodgkin Lymphoma
The Committee for Medicinal Products for Human Use has recommended approval of nivolumab for the treatment of patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin. The application for nivolumab was based in part on data from the phase II CheckMate-205 trial, in which the treatment induced responses in 66% of patients with cHL who had progressed following ASCT and brentuximab vedotin.
The responses with nivolumab were durable and included 7 complete remissions and 46 partial remissions. Among the 43 patients who did not respond to brentuximab vedotin, 72% (n = 31) responded to nivolumab. The positive opinion has been sent to the European Commission, which usually issues its final approval decision within 2 to 3 months of the CHMP recommendation. The FDA granted an accelerated approval to nivolumab in May 2016 for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after ASCT and post-transplantation brentuximab vedotin.
Venetoclax Receives Positive CHMP Opinion for CLL
The Committee for Medicinal Products for Human Use has recommended approval of venetoclax for the treatment of patients with chronic lymphocytic leukemia who have a 17p deletion or TP53 mutation and are not good candidates for or have failed on a B-cell receptor pathway inhibitor. The potential indication would also be for patients who do not harbor the deletion or mutation but have progressed on both a BCR inhibitor and chemoimmunotherapy.
Overall, 79.4% of the 106 patients evaluated in the supporting clinical trial responded to venetoclax monotherapy, according to an independent review committee evaluation. This included 8 patients (7.5%) with a complete remission or a CR with incomplete marrow recovery. Of 45 patients evaluated for minimal residual disease, 18 attained MRD-negative status in their peripheral blood. The positive opinion for the BCL-2 inhibitor has been sent to the European Commission, which usually issues its final approval decision within 2 to 3 months of the CHMP recommendation.
CMS Final Rule on MACRA Reform Eases Pressure
The Final Rule from CMS on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) was issued Friday, October 14. The rule will ease the pressure on small, rural practices to meet reporting and performance standards and explains more about the intentions behind the recently announced 2017 transition year, which is intended to make it easier for all practices to gradually move away from fee-for-service style billing.
The rule provides for guidance and financial support for smaller practices, expands the definition of Alternative Payment Models, lowers performance standards to make it easier to earn financial incentives, and simplifies prior “all or nothing” requirements for the use of electronic health record technology. The final rule and its adjustments represent a nod to the 4000 comments received by CMS in response to the Merit-based Incentive System of payments and penalties and the APM plan, designed to serve as different tracks toward value reform in medical practice.