Top news of the week in oncology and cancer drug development.
FDA Approves Rucaparib for Ovarian Cancer
The FDA has granted an accelerated approval to rucaparib as a treatment for patients with BRCA-mutant advanced ovarian cancer who have received at least 2 prior lines of chemotherapy. The approval is based on data from 106 patients across 2 trials, including the ARIEL2 study. In a pooled analysis of data from the studies, the objective response rate was 54% with rucaparib (95% CI, 44-64). The complete response rate was 9% and the partial response rate was 45%. The median DOR was 9.2 months (95% CI, 6.6-11.6). ORR rates were similar, regardless of whether patients had germline or somatic BRCA mutations, or mutations of the BRCA1 gene versus the BRCA2 gene. In addition to rucaparib, the FDA also approved FoundationFocus CDxBRCA as a companion diagnostic to detect deleterious BRCA mutations in tumor tissue. This test is the first next-generation sequencing-based companion diagnostic to gain FDA approval, according to the agency. Here's more http://www.onclive.com/web-exclusives/fda-approves-rucaparib-for-ovarian-cancer
CHMP Recommends Approval of Alectinib for ALK+ NSCLC
The Committee for Medicinal Products for Human Use has recommended approval of alectinib as a treatment for patients with metastatic ALK-positive non—small cell lung cancer following progression on crizotinib. The application is based on data from 2 phase II trials. In the first study, labeled NP28761, the overall response rate with alectinib was 52.2% (95% CI, 39.7%-64.6%) and the median progression-free survival was 8.2 months (95% CI, 6.3-12.6).
For the second trial, known as NP28673, the ORR was 50.8% (95% CI, 41.6%-59.9%) and the median PFS was 8.9 months (95% CI, 5.6-12.8). The positive opinion will now be reviewed by the European Commission. A final approval decision for use in the European Union is anticipated in early 2017.
Upfront Pembrolizumab Receives Positive CHMP Opinion for PD-L1+ NSCLC
The CHMP has recommended approval of frontline pembrolizumab for the treatment of patients with metastatic non—small cell lung cancer whose tumors do not harbor EGFR or ALK mutations. The application, which is specifically for patients with PD-L1 expression levels ≥50%, is based on data from phase III KEYNOTE-024 trial, in which single-agent pembrolizumab reduced the risk of death by 40% and improved progression-free survival by 4.3 months compared with doublet chemotherapy for untreated patients with advanced NSCLC with PD-L1 expression on ≥50% of cells.
The positive opinion will now be reviewed by the European Commission. A final approval decision for use in the European Union is anticipated by March 2017.
EC Approves Ofatumumab Combo in Relapsed CLL
The European Commission has approved ofatumumab in combination with fludarabine and cyclophosphamide as a treatment for adult patients with relapsed chronic lymphocytic leukemia.
The approval, which followed a positive recommendation from the Committee for Medicinal Products for Human Use, was based on data from the phase III COMPLEMENT-2 study, in which the median progression-free survival was 28.9 months with the addition of ofatumumab to chemotherapy compared with 18.8 months with fludarabine and cyclophosphamide alone (HR, 0.67; 95% CI, 0.51-0.88; P = .0032). The overall response rate with the triplet was 84% versus 68% in the control arm (P = .0003), with complete response rates of 27% versus 7%, respectively.
Dual Androgen Blockade Ineffective After Enzalutamide in mCRPC
Adding enzalutamide to abiraterone acetate and prednisone failed to improve progression-free survival versus abiraterone and prednisone alone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer who progressed on enzalutamide, according to findings from the phase IV PLATO trial.
The results of the study have not yet been released by the codevelopers of the androgen receptor inhibitor enzalutamide, Astellas and Pfizer. In a prior smaller study initially announced in 2013, approximately 45% of the 49 evaluable patients had a 90% or greater decline in PSA from baseline. Three-quarters of the group achieved a 50% or greater decline in PSA values from baseline while approximately 84% achieved a 30% or greater decline from baseline PSA values.
The Part B Payment Model Is Officially Dead
CMS and Representative Nancy Pelosi have confirmed the demise of the Medicare Part B Drug Payment Model “experiment” to cut margins paid to physicians on some of the most expensive drugs and introduce private sector thinking into drug purchasing and pricing systems. The Part B Drug Payment Model would set reimbursement rates based on zip codes, representing a decrease in payment for some.
In late November that CMS missed an important deadline for putting the Part B model into effect. The proposed model had drawn strenuous broadsides from the medical community, including ASCO, who contended the revision of the drug payment formula would have left physicians financially “underwater” on many drugs.
MSKCC Collaborates With Hackensack Meridian Health
Hackensack Meridian Health of New Jersey and Memorial Sloan Kettering Cancer Center announced a co-branding partnership that they say would lead to highly fruitful collaborative research and make hundreds of clinical trial opportunities available to their patients.
The announcement came on the heels of Tuesday’s signing of the $6.3 billion 21st Century Cures Act to fund precision medicine and other health initiatives, and, indeed, the 2 cancer treatment centers said they hoped to develop a joint “clinical laboratory” in the spirit of the Cures Act. Both had been expanding or upgrading their facilities in Monmouth County, for example, where Hackensack Meridian has invested part of $128 million on new linear acceleration equipment, according to John Lloyd, co-CEO of Hackensack Meridian.
21st Century Cures Act Signed Into Law
President Barack Obama signed the 21st Century Cures Act into law Tuesday, earmarking $6.3 billion over 10 years for advancements in precision medicine development, brain research, heroin and prescription drug abuse prevention, and mental health. Two years in the making, the legislation includes $1.8 billion for the Cancer Moonshot program, now renamed for Joe Biden’s son, Beau Biden, who died of a brain tumor last year.
The breakdown includes $1 billion for fighting the opioid epidemic; $1.5 billion for the BRAIN Initiative to find new ways to treat, cure and prevent brain disorders such as Alzheimer’s and epilepsy; $1.5 billion over 10 years for the Precision Medicine Initiative; and $500 million to the FDA over 10 years to speed up drug approvals and access to medical devices for patients. It also includes bipartisan mental health reforms.