Recent advances and updates in oncology and cancer drug development.
The FDA granted an accelerated approval to the BCL-2 inhibitor venetoclax as a treatment for patients with del17p-positive chronic lymphocytic leukemia following at least 1 prior therapy, based on response rates in the phase II M13-982 study. The agent was approved along with Vysis CLL FISH probe kit as a companion diagnostic for the detection of 17p deletions. In the open-label study that was pivotal in the approval, 79.4% of the 106 patients evaluated responded to venetoclax monotherapy, according to the independent review committee.
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 approval for venetoclax follows an FDA breakthrough therapy designation that was granted in April 2015 for previously treated patients with del(17p) CLL. Under the accelerated program, a full approval for venetoclax will be contingent upon findings from a larger phase III study.
Currently, there are two phase III trials assessing venetoclax in combination with anti-CD20 antibodies for patients with CLL.
The FDA has granted a priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non—small cell lung cancer who express PD-L1 and have progressed after a platinum-containing regimen, based on a collection of data from phase II studies. In the phase II BIRCH study, responses to atezolizumab were observed in up to 27% of previously treated patients with NSCLC who had the highest levels of PD-L1 expression (P = .0001).
Median overall survival was not reached in the second-line setting, with a 6-month OS rate of 76%. Similar findings were seen in the phase II POPLAR study. In patients with high PD-L1 expressing tumors the median PFS was 7.8 versus 3.9 months and the ORR was 38% and 13%, for atezolizumab and docetaxel, respectively. Under the expedited priority program, the FDA will issue a final decision on approval by October 19, 2016. The FDA is also reviewing an application for a companion IHC test for detecting PD-L1 expression.
The European Commission expanded the approval for nivolumab to include the treatment of previously treated patients with advanced renal cell carcinoma and for patients with nonsquamous non—small cell lung cancer, regardless of PD-L1 levels. The RCC indication was based on data from the pivotal CheckMate-025 trial, in which nivolumab reduced the risk of death by 27% versus everolimus, representing a 5.4-month improvement in median overall survival.
Grade 3/4 adverse events were also lower with the PD-1 inhibitor compared with everolimus. The lung cancer approval was based on data from the phase III CheckMate-057 trial, in which second-line nivolumab reduced the risk of death by 27% versus docetaxel in patients with nonsquamous NSCLC, including a 60% risk reduction among patients with the highest levels of PD-L1 expression. Nivolumab is already approved for both indications in the United States.
See more on the RCC indication: http://www.onclive.com/web-exclusives/nivolumab-approved-in-europe-for-renal-cell-carcinoma
See more on the NSCLC approval: http://www.onclive.com/web-exclusives/europe-expands-nivolumab-lung-cancer-approval
The growth in overall oncology spending kept pace with all categories of medical care, despite an increase of more than 300% for spending on biologics from 2004 to 2014, according to a report on Medicare and commercial data from the Community Oncology Alliance. For biologics, there was a 335% increase in Medicare spending from 2004 to 2014. For commercial payers, this increase was 485%. A similar trend was seen for radiation therapy, with a 204% increase for Medicare and a 66% jump for commercial payers.
Emergency department costs also increased substantial, with over a 130% increase for both types of payers. The only decrease was seen for other types of cancer drugs and chemo besides biologics, cytotoxics, and radiation. Spending on these therapies from Medicare dropped by 9%.
In addition to the costs for major services, there was a dramatic shift in site-of-service for chemotherapy infusion from community oncology centers to more expensive hospital outpatient departments, which has added to the rise in the overall cost of cancer care. In 2004, 90% of chemotherapy was administered in the community setting versus just 40% in 2014. This shift cost an estimated $2 billion in added expenses.
Eribulin mesylate has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy. The positive opinion suggests the microtubule dynamics inhibitor eribulin is likely to be approved when the European Commission issues its final decision.
Earlier this year, the FDA approved the agent for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy. The CHMP opinion was based on data from a pivotal phase III trial, Study 309, in which eribulin demonstrated a median overall survival of 15.6 months compared with 8.4 months in received dacarbazine (HR, 0.51; 95% CI, 0.35-0.75) in a cohort of 143 patients with liposarcoma. Median progression-free survival in the group was 2.9 months with eribulin versus 1.7 months with dacarbazine (HR, 0.52; 95% CI, 0.35-0.78).