May 31, 2017 - Episode 1

FDA Approval in Lung Cancer, Priority Reviews in HCC and NHL, and an ODAC Recommendation for an Epoetin Alfa Biosimilar


An FDA approval in lung cancer, priority reviews in liver cancer and non—Hodgkin lymphoma, and an ODAC recommendation for an epoetin alfa biosimilar.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has granted an approval to ceritinib as a frontline therapy for patients with metastatic ALK-positive non—small cell lung cancer.

Patients’ ALK-positive status must be determined by an FDA-approved test.

The decision is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival benefit favoring ceritinib was 8.5 months.

The ORR with ceritinib was higher at 72.5% compared with 26.7% in the chemotherapy group. The median duration of response was 23.9 months versus 11.1 months, respectively.

The FDA granted ceritinib an accelerated approval in April 2014 for the treatment of patients with ALK-positive advanced NSCLC who were previously treated with crizotinib. Today’s FDA action also converts that second-line approval into a full approval.


In hepatocellular carcinoma, the FDA has granted a priority review designation to the PD-1 inhibitor nivolumab as a treatment for patients who previously received sorafenib.

The supplemental biologics application is based on safety and efficacy results from the phase I/II CheckMate-040 study, which will be presented at the 2017 ASCO Annual Meeting.

The study included escalation and expansion phases. The overall objective response rate in the escalation phase was 15%, including 3 complete responses and 4 partial responses. Five of the 7 responses occurred with 3 months of initiating nivolumab. The median duration of response was 17 months, the median time to progression was 3.4 months, and the disease control rate was 58%.

The 6-month and 9-month overall survival rates were each 66%. Also in the dose escalation phase, the median overall survival was 15.0 months.

In the expansion phase, the ORR was 20%, including 3 complete responses and 39 partial responses, and the disease control rate was 64%.

The FDA is scheduled to make its final decision on or before September 24, 2017.


The FDA also granted a priority review to axicabtagene ciloleucel, also known as KTE-C19, for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma.

The decision was based on findings from the phase II ZUMA-1 study, in which the CD19-directed chimeric antigen receptor T-cell therapy demonstrated an objective response rate of 82% and a complete response rate of 54%. After 8.7 months of follow-up, 39% of patients continued to have a complete response.

Regarding safety, there were 4 fatal events in the study, 3 of which were deemed related to KTE-C19. The first 2 reported were from hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS. In May, Kite Pharma, the manufacturer of the therapy, noted that a patient had died from cerebral edema in the setting of grade 3 CRS with multiorgan failure. The unrelated death was from pulmonary embolism.

The FDA is scheduled to make its decision by November 29, 2017.

Kite also announced plans to file for potential approval for KTE-C19 as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma in Europe. The application is anticipated later this year.


Finally, the FDA’s Oncologic Drugs Advisory Committee voted 14 to 1 to recommend approving a biologics license application for epoetin hospira, which is an epoetin alfa biosimilar.

At this point, the BLA will go to the FDA for consideration. In 2015, the FDA did deny an abbreviated BLA by Hospira, the manufacturer of the biosimilar.

Hospira is seeking approval of the agent to treat anemia due to chronic kidney disease, including patients on dialysis and not on dialysis to decrease the need for red blood cell transfusion; to treat anemia in HIV-infected patients being treated with zidovudine; to treat chronic renal failure, specifically anemia caused by concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancy; and to reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin from more than 10 g/dL to less than or equal to 13 g/dL who are at high risk for perioperative blood loss from elective noncardiac, nonvascular surgery.

While the vote was almost unanimous, several committee members did express their concerns about immunogenicity, especially in patients with HIV or cancer.

Epoetin hospira has been available in Europe since 2008 for the treatment of anemia associated with chronic renal failure, but committee members were instructed not to take those experiences into account.


This week, Anna R. Giuliano, PhD, and Richard Kim, MD, of Moffitt Cancer Center discussed separate research findings with the human papillomavirus vaccine and non—small cell lung cancer reported on a presscast held ahead of the 2017 ASCO Annual Meeting.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.