Findings from Gastrointestinal Symposium Top Week in Cancer News
Top news of the week in oncology and cancer drug development.
FDA Approves Ibrutinib for Marginal Zone Lymphoma
The FDA has granted an accelerated approval to ibrutinib (Imbruvica) as a treatment for patients who require systemic therapy with marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy, based on findings from a single-arm phase II study. In the pivotal open-label study, the objective response rates (ORR) with ibrutinib was 46%, with a complete response rate of 3.2%, according to findings presented at the 2016 ASH Annual Meeting.
The median progression-free survival was 14.2 months with ibrutinib (95% CI, 8.3-NR) and the median overall survival was not yet reached at a median follow-up of 19.4 months. In those with extranodal or mucosa-associated lymphoid tissue disease, the ORR was 46.9%. In the nodal group, the ORR was 41.2% and in the splenic arm the ORR was 50%. After a median follow-up of 19.4 months, the median duration of response was not reached (range, 16.7-NR).
The median time to initial response was 4.5 months (range, 2.3-16.4). The accelerated approval for MZL is contingent upon findings from a larger confirmatory study. Ibrutinib has previously been approved by the FDA for the treatment of patients with mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, and Waldenström’s macroglobulinemia.
2017 Gastrointestinal Cancers Symposium
The 2017 oncology conference calendar officially kicked into high gear this week with the Gastrointestinal Cancers Symposium. As expected, several of the most buzzworthy abstracts involved PD-1 inhibitors. In one study, treatment with nivolumab (Opdivo) reduced the risk of death by 37% compared with placebo for patients with advanced gastric or gastroesophageal junction (GEJ) cancer following second or later-line chemotherapy.
In a combination trial, pembrolizumab (Keytruda) plus ramucirumab (Cyramza) demonstrated modest activity in patients with previously treated GEJ cancer. Four of 41 patients had partial responses to treatment with pembrolizumab and 2 different doses of ramucirumab. Almost half of the patients achieved disease control, which included stable disease.
Another study of interest involved the the multikinase inhibitor cabozantinib, which demonstrated clinical activity in patients with advanced carcinoid and pancreatic neuroendocrine tumors (pNETs) in a single-arm phase II trial. Partial responses were observed in 15% of each cohort treated with cabozantinib and stable disease was the best response in about two-thirds of patients.
Median progression-free survival exceeded 20 months in the pNET cohort and was more than 30 months in the carcinoid tumor cohort
For complete coverage of the GI Symposium, visit: http://www.onclive.com/conference-coverage/gi-2017
Frontline Immunotherapy Combo Setbacks Strike NSCLC
Bristol-Myers Squibb (BMS) and AstraZeneca have each announced separate delays in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non—small cell lung cancer (NSCLC), according to statements from each of the companies. In its statement, BMS noted that it would not be pursuing an accelerated approval for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline therapy for NSCLC.
Instead, the company plans to delay the submission of data to the FDA until findings from a phase III study are available, most likely from the phase III CheckMate-227 trial. Earlier this week, AstraZeneca also described modifications to its clinical development program for the combination of the PD-L1 inhibitor durvalumab with the CTLA-4 inhibitor tremelimumab. The primary endpoint of the phase III MYSTIC trial exploring the combination was adapted to include overall survival (OS) in addition to progression-free survival (PFS).
With this change, the company now expects data for PFS in mid-2017 and findings for OS in 2018. At this time, the MYSTIC trial is no longer recruiting new participants (NCT02453282). In addition to this change, AstraZeneca also expanded the phase III NEPTUNE trial, which is also exploring the combination of durvalumab and tremelimumab. Data for OS from this trial are anticipated in 2018. Additionally, a new phase III study, labeled PEARL, is being launched to further explore frontline durvalumab monotherapy for patents with PD-L1—positive NSCLC.
RCCA Widens Range With Connecticut Partnership
Regional Cancer Care Associates (RCCA) has continued its expansion along the East Coast by adding 2 Connecticut-based cancer centers with 6 cancer specialists to its network of independent practices. RCCA’s network expansion mirrors a growing trend of practices aligning with other independents or joining hospital systems to overcome the challenges of competition, costly care, and changing payment patterns.
The group now has 29 locations, anchored by the Hackensack Meridian Health hospital group, and first stepped across state lines in October 2015, when the organization spread from its New Jersey base to Maryland and Washington, DC. It encompasses more than 100 oncologists, 28 advanced practice nurses, 100 registered nurses, and 750 staff members. RCCA has built itself into a competitive force and claims the ability to do more than 23,000 new patient consults per year.
It offers personalized cancer care and works with primary physicians and local hospitals to coordinate treatment. It also includes nonmedical support, such as yoga, spiritual support, and nutritional counseling. Officials said the new Connecticut partnership fits with RCCA’s mission to provide convenient access to comprehensive, patient-centered treatment, and it comes after a significant amount of activity to strength the oncology program offerings throughout the RCCA network. In June of 2016, Hackensack University Health Network merged with Meridian Health. The resulting entity, Hackensack Meridian Health, has 11 hospitals across New York and New Jersey and is part of the RCCA network.
Trump’s Ascension to Spell Swift End to ACA
Just hours after taking the oath of office, President Donald J. Trump signed an executive order calling for the prompt repeal of the Affordable Care Act (ACA). The executive order, which was labeled "Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal," noted that until the ACA was repealed that it would be implemented efficiently, with an emphasis on allowing states the ability to create free and open healthcare markets.
The order stressed that the heads of all executive departments and agencies, including the Secretary of Health and Human Services, should attempt to bypass any portions of the law that would result in fiscal burdens to states and multiple other stakeholders, including healthcare providers, families, and individuals. Along with promoting every effort to waive, defer, grant exemptions from, and delay the implementation of the law, the executive order also advised the department heads to be "flexible" with states on the implementation of healthcare programs, to the maximum extent possible within the confines of the law.
In an effort to build a replacement for the ACA, the order advised all heads of departments and agencies involved in health care or health insurance to begin taking part in the development of a new free and open market. This new market was described as allowing "interstate commerce for the offering of health care services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers."