Top news of the week in cancer drug development.
Top news of the week in cancer drug development.
2015 ASH Abstract Release
Last week, the ASH Abstracts were released, which sparked a flood of early news items, including one on an 11-month-old with CD19+ ALL who received the "out of the box gene therapy" UCART19. She had progressed on bone marrow transplant and blinatumomab.
With a poor outlook, she was given the experimental therapy, and within a matter of weeks exhibited signs of count recovery and bone marrow that was in cytogenetic and molecular remission. Cellectis, which is partnered with Pfizer, will hope to replicate this first experience in future trials.
Among the abstracts release were findings from the Tourmaline-MM1 Study, which Takeda has been guarding closely. In the study, the addition of ixazomib to lenalidomide and dexamethasone showed a median progression-free survival of 20.6 months compared with 14.7 months without the oral proteasome inhibitor for patients with myeloma (HR, 0.74; P = .012).
The response rate was 78.3% with ixazomib and 71.5% without. Additionally, toxicity was not substantially increased. The FDA is currently reviewed these data.
While announcing 45 abstracts at the ASH meeting, Genentech also released that the FDA had granted a priority review to obinutuzumab for non-Hodgkin lymphoma based on data from the GADOLIN study, which were presented initially at the ASCO Annual Meeting.
Based on the priority review timeline, the agency will make a decision on the application within 6 months. In addition to this milestone, a new drug application has also been submitted for venetoclax in 17p deletion CLL.
CFS 2015 Highlights Treatment Trends
At the Chemotherapy Foundation Symposium, there were a number of sessions on the latest news from across a broad array of cancer types.
A talk by Susan O'Brien, MD, focused on treating patients with chronic lymphocytic leukemia using the novel agents ibrutinib and idelalisib. The talk focused on these agents’ efficacy and tips for managing adverse events.
Another talk by Maurie Markman, MD, zeroed in on immunotherapy in ovarian cancer. Markman contended that practically every trial shows an objective response rate of 10% to 20% in ovarian cancer and therefore early findings for immune checkpoint inhibitors should be taken with a grain of salt, while larger trials are conducted.
Another area of interest is the rapidly changing melanoma treatment paradigm and, for the first time, CFS featured discussions on dermatologic oncology. In a discussion by Jeff Weber, MD, PhD, he described the high level of efficacy seen with BRAF/MEK combinations and identified an ideal population for the combination versus immunotherapy.
For slow growing BRAF-positive tumors, he suggested immunotherapy might be ideal; however, for rapidly growing BRAF-positive melanoma, the combination of dabrafenib and trametinib is the best choice.
NY Lung Focuses on Immunotherapy
Following FDA approvals for nivolumab and pembrolizumab for patients with non—small cell lung cancer, the focus at the NY Lung Cancer Symposium was very much on the use of these agents. In his talk, Renato Martins, MD, MPH, suggested that nivolumab should be offered to all patients in the second-line setting, regardless of histology or PD-L1 status.
Conference co-chair, Roman Perez-Soler, MD, echoed these sentiments, saying that PD-1 inhibitors should be used in the second-line setting for nearly all patients. He called the immunotherapies a "gift for thoracic oncologists."
In addition to nivolumab, Perez-Soler is optimistic that data from KEYNOTE-010 will lead to an expansion in the pembrolizumab label, to allow for PD-L1 expression of ≥1% rather than the current ≥50%.
In addition to approved indications, CTLA-4, PD-1, and PD-L1 inhibitors are also being explored for patients with small cell lung cancer and mesothelioma. The results of a number of clinical trials in these settings have been reported, with promising findings so far. Ongoing studies will continue to assess these approaches.
AACR Meeting Showcases Early Phase Research
This past week, AACR-NCI-EORTC hosted the International Conference on Molecular Targets and Cancer Therapeutics, which featured a collection of early phase and preclinical research.
In a small analysis of 17 patients with heavily pretreated platinum-resistant ovarian cancer, the FRα-targeting antibody-drug conjugate mirvetuximab soravtansine demonstrated promising preliminary clinical activity.
In the full study cohort, the response rate was 53% and in an FRα high group, there was an ORR of 80%. In 55 patients with IDH1-mutant solid tumors, including gliomas, AG-120, which has shown promise for blood cancers, was found to be moderately effective.
Most patients had stable disease at the time of the analysis, with a few showing a partial response. However, these results were below expectations, causing the stock to drop by 10%.
See more at: http://bit.ly/agios-stock
The selective EGFR inhibitor AZD9291 showed promise in non—small cell lung cancer with leptomeningeal disease, a rare condition effective the brain and spinal cord. Overall, the treatment led to improvements in symptoms and 72% of patients were showing signs of a response on scans.
See more at: http://bit.ly/azd9291-rare