Clinical Hold on Oncology Drug After Patient Deaths in Top Cancer News


Top news of the week in oncology medication development.

Giants of Cancer Care 2016

The Giants of Cancer Care program recognizes those physicians and researchers who have devoted their time, talent, and resources to improving the care for the many patients and their families affected by cancer. Now in its fourth year, the program has been well received, with nearly 40 Giants selected so far. For 2016, 100 nominations have already been received, with nominations still being collected online (if you haven't yet, nominate at

This year, there will be two events. First, a dinner reception in Chicago in June to announce/acknowledge all 2016 nominees and recognize the efforts of the Advisory Board and Selection Committee prior to the ASCO Annual Meeting. Finally, the 2016 winners will be announced at the 4th annual Giants of Cancer Care awards celebration during the 34th Annual Chemotherapy Foundation Symposium in New York City in November.

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Pacritinib Placed on Clinical Hold

The FDA has placed a full clinical hold on trials exploring pacritinib, following reports of patient deaths related to intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial, according to a statement from CTI BioPharma, the developer of the JAK2/FLT3 inhibitor. Under the hold, all patients have been taken off clinical trials and required to discontinue treatment with pacritinib. To rectify the hold, the FDA recommended that CTI BioPharma should conduct additional dose exploration studies for pacritinib in patients with myelofibrosis.

Moreover, the agency asked the company to amend existing protocols, revise consent forms and investigator brochures, and submit final data from the PERSIST-2 trial and the earlier phase III PERSIST-1 study for further review. Pacritinib had demonstrated promising data in the PERSIST-1 trial, which was presented at the 2015 ASCO Annual Meeting. In this study, the tyrosine kinase inhibitor demonstrated improvements in spleen volume and symptom control versus best available therapy for patients with myelofibrosis. Findings from the PERSIST-1 trial had been submitted to the FDA; however, following the clinical hold, CTI BioPharma announced that it had withdrawn its new drug application.

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ODAC Meeting Schedule for Rociletinib in NSCLC

The FDA has scheduled an ODAC advisory hearing for April 12, 2016, to discuss the new drug application for rociletinib as a treatment for patients with metastatic EGFR T790M­­-mutated non—small cell lung cancer. A rolling submission was completed for the EGFR inhibitor in July 2015, which was subsequently granted a priority review by the FDA.

However, at a preplanned 90-day review meeting changes in response rates from two pivotal ongoing single-arm trials prompted the FDA to request additional data, which set off a chain of events leading to the scheduling of the ODAC hearing. Prior to scheduling the ODAC hearing, Clovis had announced that the FDA extended the review period for rociletinib by 3 months, to allow ample time to review the new data.

The current action date for rociletinib is June 28, 2016. In the updated results released by Clovis following the 90-day review, evaluable patients treated with the 500 mg dose of rociletinib (n = 79) experienced a confirmed objective response rate of 28%. Additionally, in 170 patients treated with the 625 mg dose, the confirmed ORR was 34%. The duration of response for both doses was 9 months.

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Novel Immunotherapy Granted Breakthrough Designation for Sarcoma

An affinity enhanced T-cell therapy has received an FDA breakthrough therapy designation for the treatment of patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen.

The breakthrough designation, which will expedite the development and review of this novel T-cell therapy in synovial sarcoma, is based on a phase I/II trial in which the treatment induced a response rate of 50% in patients with unresectable, metastatic, or recurrent synovial sarcoma treated with prior chemotherapy.

Ten of the 12 patients received the target dose of 1 to 6 billion total engineered T cells. Among these 10 patients, 6 (60%) had a response. The 2 patients who did not receive the target dose did not have a response, so the overall response rate (ORR) for the 12 total patients was Ninety percent (9/10) and 75% (9/12) of the patients receiving the target or any dose, respectively, remained alive and in follow-up at the time of the data analysis.

Survival data beyond 1 year are available for 5 of the 12 patients (42%) overall. Forty-two percent (5/12) of patients who received any dose have survival data beyond one year.

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Pivotal Data Published in Lancet

Findings from two important studies focused on therapies for patients with breast cancer and non—small cell lung cancer were published last week in Lancet Oncology. In the first, data were published for neratinib in the phase III ExteNET study. In this phase III trial, which was also presented at the 2015 ASCO Annual Meeting, the 2-year DFS rate with neratinib was 93.3% versus 91.6% with placebo for patients with early HER2-positive breast cancer (HR, 0.67; P = .009). In patients with both HER2- and HR-positive disease, the 2-year DFS rate was 95.4% with neratinib and 91.2% with placebo, representing a 49% benefit (HR, 0.51; P = .001).

The second published study contained data for the PD-L1 inhibitor durvalumab combined with the CTLA-4 inhibitor tremelimumab for those with NSCLC. The objective response rate with durvalumab plus tremelimumab was 23%, and was experienced by patients regardless of PD-L1 status. AstraZeneca, the company developing the agents, has launched phase III trials examining the durvalumab/tremelimumab combination in the first-line NSCLC setting.

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