Lymphoma Drug Approval Tops Week in Cancer News


Top news of the week in oncology and cancer drug development.

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FDA Approves Pembrolizumab for Hodgkin Lymphoma

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) who are refractory or have relapsed after 3 or more lines of therapy. The approval is based on data from the nonrandomized, open-label KEYNOTE-087 trial, in which, at a median follow-up of 9.4 months, the overall response rate (ORR) with pembrolizumab was 69% (95% CI, 62-75).

The ORR included complete responses in 22% of patients and partial responses in 47% of patients. The median duration of response was 11.1 months (range, 0+ to 11.1) among the 145 responding patients. The specific pembrolizumab regimens approved are 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatric patients. This is the first FDA indication for pembrolizumab in a hematologic malignancy. Pembrolizumab’s label was also updated with a new "Warning and Precaution" for complications of allogeneic hematopoietic stem cell transplantation after treatment with the PD-1 inhibitor.

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Abemaciclib Improves PFS in Phase III Breast Cancer Trial

Adding abemaciclib to fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 2 study, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor. Lilly plans to submit the MONARCH 2 data to the FDA for regulatory review by the third quarter of this year.

Prior to that submission, the company intends to submit an application, based on the MONARCH 1 trial, for single-agent abemaciclib for the treatment of patients with refractory metastatic breast cancer who have disease progression after endocrine therapy and 1 to 2 chemotherapy regimens in the metastatic setting. The international, double-blind phase III MONARCH 2 trial randomized 669 patients in a 2:1 ratio to abemaciclib plus fulvestrant or fulvestrant alone. Patients had progressed during or within 1 year of receiving endocrine therapy in the neoadjuvant or adjuvant setting, or during frontline endocrine treatment for metastatic disease.

Individuals were excluded from enrollment if they were administered chemotherapy in the metastatic setting. The primary endpoint for the trial was PFS. According to Lilly, the safety data were consistent with results reported in previous trials of abemaciclib. The most common adverse events observed were diarrhea, neutropenia, nausea, and fatigue.

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Maintenance Olaparib Shows Impressive PFS Benefit for BRCA+ Ovarian Cancer

Maintenance therapy with olaparib (Lynparza) showed a 70% reduction in the risk of progression or death compared with placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer, according to phase III SOLO2 findings reported at the 2017 Society of Gynecologic Oncology meeting. Patients randomized to receive olaparib had a median investigator-assessed progression-free survival (PFS) of 19.1 months compared with 5.5 months in the placebo arm (HR, 0.30; 95% CI, 0.22-0.41; P <.0001).

A prespecified analysis of PFS by a blinded central review committee showed a median PFS of 30.2 months for the olaparib group versus 5.5 months for placebo, a 75% reduction in the hazard for progression and death (HR, 0.25; 95% CI, 0.18-0.35; P <.0001). The secondary endpoint of median time to first subsequent therapy or death was 27.9 months with olaparib and 7.1 months with placebo (P <.0001). The median PFS2 had yet to be reached in the olaparib group, whereas the placebo group had median of 18.4 months, representing a 50% reduction in the hazard ratio in favor of the PARP inhibitor (P = .0002). Time to second subsequent therapy or death also had yet to be reached in the olaparib arm compared with a median of 18.2 months in the placebo group (P <.0001). Data remained too immature for an analysis of overall survival.

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Binimetinib NRAS-Mutant Melanoma Application Withdrawn

Array BioPharma has withdrawn its new drug application (NDA) for the MEK inhibitor binimetinib as a treatment for patients with NRAS-mutant advanced melanoma, based on feedback from the FDA during a preplanned review meeting. The application for binimetinib was based on data from the phase III NEMO study, which was presented at the 2016 ASCO Annual Meeting.

In the open-label study, median progression-free survival (PFS) with binimetinib was 2.8 versus 1.5 months with dacarbazine, representing a 38% reduction in the risk of progression or death (HR, 0.62; 95% CI, 0.47-0.80; P <.0001); however, overall survival (OS) was not improved with the MEK inhibitor.

In addition to NRAS-mutated tumors, binimetinib was also explored in combination with the BRAF inhibitor encorafenib as a treatment for BRAF-mutant melanoma in the phase III COLUMBUS trial. The median PFS with the combination by independent review was 14.9 months with encorafenib plus binimetinib versus 7.3 months for vemurafenib (HR, 0.54; 95% CI, 0.41-0.71; P <.001). The withdrawal of the NRAS-mutant application will not impact the filing of data for an NDA from the COLUMBUS trial, Array noted in the statement. This application is anticipated by the middle of 2017.

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ASCO, ASH Speak Out Against Proposed NIH Funding Cut

President Donald Trump has called his fiscal year (FY) 2018 budget proposal a “blueprint for making America great again,” but oncological societies have been quick to denounce the budget plan, released Thursday, March 16, as a huge potential setback to health efforts in general and specifically to the fight against cancer. The budget proposal calls for a $5.8 billion cut—nearly 19%&mdash;in funding for the National Institutes of Health, which, through the National Cancer Institute, supports a significant amount of cancer research, including clinical trials, at independent institutions around the country.

The NIH had a FY 2016 budget of $32 billion, and in the yet nonfinalized FY2017 budget the agency would receive $34 billion. The budget proposal calls for dramatic cuts in various other types of health spending and is part of Trump’s plan to increase military spending by $54 billion next year largely by drawing from nonmilitary spending. The cuts if approved would leave the NIH with a budget of $25.9 billion and would involve a major reorganization of NIH institutes and centers to refocus resources on “the highest priority research and training activities,” according to the Trump budget plan.

In introducing the budget plan, which cut spending in departments besides the NIH, Trump explained his priorities. “A budget that puts America first must make the safety of our people its number one priority—because without safety, there can be no prosperity,” Trump said. “…To keep Americans safe, we have made tough choices that have been put off for too long. But we have also made necessary investments that are long overdue.”

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