Adverse Events Halt Drug Trials in Top Cancer News


Recent advances and updates in oncology and cancer drug development.

FDA Halts 6 Idelalisib Studies

Six clinical trials exploring idelalisib (Zydelig) in combination other therapies have been halted due to reports of an increased rate of adverse events, including death, according to an alert issued by the FDA. The studies that were stopped were exploring idelalisib in chronic lymphocytic leukemia, small lymphocytic lymphoma, and indolent non-Hodgkin lymphomas.

The FDA announcement follows a similar decision from the European Union to place idelalisib under a safety review, following reports of infections that were associated with the medication. Idelalisib is currently approved for CLL in combination with rituximab and for follicular lymphoma and SLL as a monotherapy following at least two prior therapies.

The FDA noted in its alert that idelalisib is currently not approved for untreated patients with CLL. In addition to CLL, SLL, and indolent NHL, idelalisib is also being explored in various solid tumors. It remains unclear at this point whether these studies will be impacted by the hold.

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Crizotinib Approved for ROS1-Positive NSCLC

The FDA approved crizotinib as a treatment for patients with ROS1-positive metastatic non—small cell lung cancer, based on the demonstration of substantial efficacy in a phase I study. In the trial, which enrolled 50 patients with ROS1-positive NSCLC, the overall response rate (ORR) was 66% with a median duration of response of 18.3 months by independent review. The ORR was 72% by investigator assessment, which was comprised of 3 complete responses (6%) and 33 partial responses (66%).

An additional 9 patients (18%) had stable disease as their best response for an overall disease control rate of 90%. By investigator assessment, the median time to first response was 7.9 weeks and the median duration of response was 17.6 months. The approval was preceded by a breakthrough therapy designation and arrived approximately one month ahead of a deadline set under the Prescription Drug User Fee Act.

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Expanded Indication Sought for Ofatumumab in CLL

A supplemental new drug application has been submitted to the FDA for ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia, based on an improvement in progression-free survival in the phase III COMPLEMENT-2 study. In the open-label study, the median PFS was 28.9 months with the addition of ofatumumab compared with 18.8 months with chemotherapy alone (HR, 0.67; 95% CI, 0.51-0.88; P = .0032).

The overall response rate with the triplet was 84% versus 68% in the control arm (P = .0003), with complete response rates of 27% versus 7%. The FDA will review the application, which was submitted by Novartis, within 60 days, at which point the agency will assign a decision deadline under the Prescription Drug User Fee Act. Under a standard review, the agency will make a ruling on the medication within 10 months.

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Miami Breast Cancer Conference

Recently the Miami Breast Cancer Conference was keynoted by Amy Robach, from Good Morning America. At the meeting, Robach talked about the importance of beginning annual breast cancer screening at age 40. She was 40 when she got diagnosed with a stage II ER-positive breast cancer, after receiving a mammogram on live TV.

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The meeting was filled with valuable information and presentations. During the poster session, Dejan Juric, MD, presented findings on the combination of the alpha-specific PI3K inhibitor alpelisib and fulvestrant, which demonstrated promising early efficacy and mild toxicity in heavily pretreated postmenopausal women with ER-positive metastatic breast cancer. The combination is now in phase III studies.

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On the first day of the meeting, Gunter von Minckwitz, MD, PhD, presenting on the need for more data to confirm the early findings for carboplatin in BRCA-mutant triple-negative breast cancer. At this time, there is currently a phase III and a phase II study underway, to potentially provide the needed data to solidify carboplatin as the standard of care.

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For more from the conference, visit

Intriguing Studies Presented at EAU Congress

A number of findings were presented this past weekend at the European Association of Urology (EAU) Congress, including one that suggests that low levels of testosterone predicts a higher Gleason score. In this study, men with hypogonadism and levels of sex-hormone-binding globulin could be used to predict a Gleason score of 5+5 (here's more

In another study, men receiving active surveillance had quality of life that was similar to men without prostate cancer or for those who received treatment. When compared with radical prostatectomy, men in the active surveillance arm reported better urinary function, less urinary incontinence, and better sexual function.

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Earlier Abiraterone More Effective for mCRPC

Treatment with abiraterone acetate plus prednisone demonstrated an 11.8-month improvement in overall survival compared with prednisone and placebo for men with less advanced, chemotherapy-naïve metastatic castration-resistant prostate cancer, according to a post-hoc analysis of the phase III COU-AA-302 trial presented at the EAU congress.

Median OS with abiraterone was 53.6 months compared with 41.8 months with placebo for men with a PSA below 80 ng/ml, Gleason score below 8, and a brief pain inventory score of 0 to 1. This improvement in OS was equivalent to a 39% reduction in the risk of death (HR, 0.61; P = .0055). Across the full study, abiraterone demonstrated a 4.4-month improvement in OS versus placebo (HR, 0.81; P = .0033).

In men with more aggressive disease, the median OS was improved by 2.8 months with abiraterone (HR, 0.84; 95% CI, 0.72-0.99; P = .0321). In addition to OS, time to chemotherapy, time to opiate use, and median time on treatment were also significantly improved for men with less aggressive mCRPC.

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