ASCO Guiding Principles for Congress Tops Week in Cancer News


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

FDA Grants Priority Review to Frontline Pembrolizumab Combo for NSCLC

The FDA has granted a priority review to Merck’s supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with pemetrexed plus carboplatin as a treatment for patients with metastatic or advanced non-squamous non—small cell lung cancer (NSCLC) without EGFR or ALK mutations and regardless of PD-L1 expression. Single-agent pembrolizumab was already approved by the FDA for frontline NSCLC in October 2016.

The target action date for the new application is May 10, 2017. Approval is not a sure thing as the supporting data come from a small, phase II trial. Many analysts had expected the filing to come later after phase III data were available. However, if successful, Merck would achieve a major victory with first-mover advantage over competitors developing immunotherapy combinations for frontline NSCLC, including Bristol-Myers Squibb, Roche, and AstraZeneca.

The sBLA was based on part 2 of cohort G in the phase II KEYNOTE-021 trial, in which the pembrolizumab triplet elicited an objective response rate of 55% compared with 29% with the chemotherapy agents alone (P = .0016). The median progression-free survival was 13.0 months with the addition of pembrolizumab versus 8.9 months for chemotherapy alone (HR, 0.53; 95% CI, 0.31-0.91; P = .010).

After 10.6 months of follow-up, 88% of those in the pembrolizumab arm remained alive and progression-free compared with 78% for the chemotherapy agents alone. The median time to response was 1.5 months with pembrolizumab compared with 2.7 months for the chemotherapy agents alone. Overall, a response of at least 6 months was seen for 92% of patients in the pembrolizumab group compared with 81% of those in the control arm.

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Cota Announces New Version of OCM Solution for Health Care Providers

Cota, a New York-based precision informatics company, has developed what it says will be a significant aid for oncology practices working to conform to the expectations of CMS’s Oncology Care Model (OCM), which is designed to encourage physicians to strive for better patient outcomes and lower costs. The new tool, Cota OCM, is one of many attempts recently to help physicians overcome the manually intensive and sometimes inflexible electronic health record (EHR) systems they are increasingly required to use for CMS reporting.

Cota, which for the past decade has been developing software for organizing and making better use of patient data, says its newest product will help oncology practices to simplify the process of meeting reporting requirements under the OCM, which CMS launched this year with 190 participating practices. The product takes account the many different quality measures upon which practice performance may be measured and allows for automated data collection and reporting.

The product is also adaptable for use with other CMS-based quality improvement programs. OCM participants have long been challenged by the difficulty of how to gather and report quality metrics data without using excessive amounts of staff time. Some practice administrators have complained of large manual data uploading tasks.

Cota OCM is an outgrowth of what the company calls its nodal address system (CNA Guided Care Platform), a big data effort to collect and categorize large quantities of patient information and facilitate the analysis of that data in order to arrive at a better understanding of how specific therapies will work with individual patients. The nodal address system from Cota takes raw structured and unstructured patient data from any EHR platform and converts it into a form usable for analysis. The company says its newest offering automates many functions for the convenience of providers.

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FDA Rejects Application for Intravenous Rolapitant

The FDA has rejected Tesaro’s application for an intravenous (IV) formulation of rolapitant for use in the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. Oral rolapitant (Varubi) was approved by the FDA in September 2015. Tesaro received a complete response letter from the FDA explaining its decision on the IV formulation.

The letter requested further information related to the in vitro method used to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the application. The letter did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. "Tesaro is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA's questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017," Mary Lynne Hedley, PhD, president and COO of Tesaro, said in a statement.

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Valeant Sells Dendreon to Chinese Company

Valeant has agreed to sell Dendreon to Sanpower group, one of the largest, privately-owned conglomerates in China, for $820 million. Valeant purchased Dendreon in February 2015 for $495 million. Prior to the Valeant purchase, Dendreon, the maker of the first FDA-approved immunotherapy for advanced prostate cancer, sipuleucel-T (Provenge), filed for chapter 11 bankruptcy in November 10, 2014.

The FDA approved sipuleucel-T in April 2010 as a treatment for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). This approval was based on a 4.1-month extension in overall survival (OS) in men treated with the immunotherapy compared with placebo. In the pivotal IMPACT study, 512 men with mCRPC were randomized in a 2:1 ratio to receive sipuleucel-T (n = 341) or placebo (n = 171). The median OS with sipuleucel-T was 25.8 months versus 21.7 months with placebo (HR = 0.78; 95% CI, 0.61-0.98; P = .032). Following its approval in the United States, sipuleucel-T gained recommendations across several guidelines, including those created by NCCN and AUA.

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ASCO Addresses Impending Obamacare Repeal

And finally, as the repeal of Obamacare is soon likely to become official after the inauguration of Donald Trump, the American Society of Clinical Oncology (ASCO) has released guiding principles that the new Congress and administration can use to ensure that the focus does not waiver from the patient (link to ASCO principles:

The primary emphasis of these principles is to ensure access to healthcare and adequate insurance to improve outcomes among those diagnosed with cancer. Pointing out that uninsured and underinsured families often decide to forego cancer care because of the impending out-of-pocket cost burden, ASCO thinks that this is a form of avoidable stress for patients and their families.

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