Top news of the week in oncology and cancer drug development.
FDA Grants Priority Review to Pembrolizumab for MSI-H Cancer
The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced microsatellite instability-high cancer. The sBLA is based on results from 5 open-label, multicohort phase I/II trials that evaluated pembrolizumab in patients with MSI-H tumors.
The specific regimen would be a fixed dosed of 200 mg of pembrolizumab every 3 weeks. In the findings presented at ASCO in 2015, the objective response rate was 62% with pembrolizumab in mismatch repair-deficient metastatic colorectal cancer compared with 0% in patients with MMR-proficient tumors. Median progression-free survival and overall survival were not reached, with many patients responding to treatment for longer than 12 months in the MMR-deficient arm.
In separate findings presented in January at the 2016 Gastrointestinal Cancers Symposium, treatment with pembrolizumab produced an ORR of 47% in a phase II trial of patients with noncolorectal GI cancers whose tumors were mismatch repair-deficient. Responses ranged from 4 months to 20 months, and all responders were still on treatment at the time of the data presentation. Under the expedited review, the FDA is scheduled to make a final decision by March 8, 2017.
See more: http://www.onclive.com/web-exclusives/fda-grants-priority-review-to-pembrolizumab-for-msih-cancer
Two Deaths Force Hold for Phase II Trial of JCAR015 in ALL
For a second time, a clinical hold has been placed on the phase II ROCKET study exploring the CD19-targeted CAR T-cell therapy JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, according to Juno Therapeutics. The hold was voluntarily initiated by Juno after 2 patients experienced cerebral edema earlier this week.
Both patients have died, according to Juno. The company is now in discussions with the FDA and the data safety monitoring board to assess its options with the JCAR015 program. The FDA previously placed a clinical hold on the ROCKET study in July 2016 to address 3 deaths from cerebral edema that occurred following the addition of fludarabine as part of a preconditioning regimen given prior to JCAR015.
The hold was lifted only 1 week after it was placed on the study, after Juno submitted and the FDA accepted a new protocol design in which preconditioning consisted of cyclophosphamide alone. However, these additional deaths call the fludarabine theory into question, as this change was conducted. It is unclear when or if the trial will be resumed.
See more: http://www.onclive.com/web-exclusives/clinical-hold-again-placed-on-phase-ii-trial-of-jcar015-in-all
Ixazomib Granted Conditional European Approval for Myeloma
The European Commission has granted a conditional approval to ixazomib in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma following at least 1 prior therapy, based on a near 6-month improvement in progression-free survival in the phase III TOURMALINE-MM1 study. In the pivotal study, the median PFS with the ixazomib triplet was 20.6 months compared with 14.7 months with lenalidomide and dexamethasone alone (HR, 0.74; 95% CI, 0.59-0.94; P = .01).
A very good partial response or better was achieved by 48% of those treated with ixazomib versus 39% in the control arm (P = .01). The conditional approval follows a positive opinion from the Committee for Medicinal Products for Human Use, which was granted in September. Under the conditional program, the developer of the oral proteasome inhibitor, Takeda, will be required to submit additional data from ongoing studies to support continued authorization.
See more http://www.onclive.com/web-exclusives/ixazomib-granted-conditional-european-approval-for-myeloma
EC Approves Nivolumab for Hodgkin Lymphoma
The European Commission has approved nivolumab for the treatment of patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin. The approval was based on an objective response rate of 66% (95% CI, 56-76; n = 63) in a combined analysis of 95 patients with relapsed or refractory cHL who received nivolumab either in the phase II CheckMate-205 trial or the phase I CheckMate-039 trial.
The complete response rate was 6% (n = 6) and the partial response rate was 60% (n = 57). The 12-months progression-free survival rate was 57%. The EC’s approval decision followed a positive recommendation from the Committee for Medicinal Products for Human Use. Nivolumab is now approved for use in relapsed or refractory cHL in the 28 countries of the European Union, making it the first anti—PD-1 agent approved in the EU for a hematologic malignancy.
See more: http://www.onclive.com/web-exclusives/ec-approves-nivolumab-for-hodgkin-lymphoma
Part B Payment Experiment Unlikely
The future looks grim for the Medicare Part B payment experiment, as a key date for the plan has passed and the Trump administration is primed to reject the model, according to a statement from the Community Oncology Alliance. The Part B Drug Payment Model would set reimbursement rates based on zip codes, representing a decrease in payment for some. According to the original plan, the proposed drug model could not be put into effect until 60 days after the release of the final rule.
Had the rule been released last week, the Obama administration would still be in office in time to implement the program. Now, in 60 days’ time, the Trump administration will be in charge, and there is little support among Republicans for the payment model. While it was not as quick to call the Part B dead, ASCO in Action was also hopeful that the demo had stalled, heading into the Thanksgiving break. Both ASCO and COA lobbied to prevent the release of the final rule. The controversial reimbursement experiment is now unlikely to see the light of day.
See more: http://www.onclive.com/web-exclusives/coa-declares-early-victory-in-cms-part-b-payment-battle