FDA Submission Completed for Brigatinib in ALK-Positive NSCLC

Excerpt:

“A new drug application (NDA) has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non–small cell lung cancer (NSCLC) following resistance or intolerance to crizotinib (Xalkori), according the developer of the ALK inhibitor, Ariad Pharmaceuticals.

“The application was based on findings from the phase II ALTA study, which was presented at the 2016 ASCO Annual Meeting, along with results from an earlier phase I/II trial. In ALTA, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54%, which included a complete response rate of 4%. In those with measurable, active brain metastases treated with the 180 mg dose (n = 18), the intracranial ORR was 67%. Median progression-free survival (PFS) was 12.9 months.”

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Wolchok Discusses T-VEC, Other Immunotherapy Developments in Melanoma

Excerpt:

“Melanoma research is rapidly advancing, particularly with immunotherapy, explains Jedd D. Wolchok, MD, PhD.

“ ‘With immunotherapy, we have come an extremely long way in the treatment of melanoma,’ says Wolchok, the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation, chief, Melanoma and Immunotherapeutics Service, associate director, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center.

“Combination trials with immunotherapies offer great promise, he says. Recently, the combination of talimogene laherparepvec (T-VEC; Imlygic) and ipilimumab (Yervoy) in patients with advanced melanoma demonstrated an objective response rate of 50% in a single-arm phase Ib trial after a median follow-up time of 20 months. Forty-four percent of patients had a durable response lasting more than 6 months; after 18 months, progression-free survival (PFS) was 50% and overall survival was 67%.”

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Excitement Continues to Build for Advances in Neuroendocrine Tumor Field

Excerpt:

“It’s been an exciting year thus far for patients with neuroendocrine tumors (NETs), with the FDA approving a new treatment regimen and more advancements on the horizon, according to James C. Yao, MD, a professor in the Department of Gastrointestinal (GI) Medical Oncology at The University of Texas MD Anderson Cancer Center.

“In February, the FDA approved everolimus (Afinitor) as a treatment for patients with progressive, well-differentiated, non-functional NETs of GI or lung origin with unresectable, locally advanced or metastatic disease. The mTOR inhibitor has been approved since 2011 for unresectable or advanced pancreatic NETs.

“Meanwhile, the agency is evaluating Lutathera (177Lutetium DOTA-octreotate), a peptide receptor radionuclide therapy (PRRT), for patients with gastroenteropancreatic NETs under its priority review program. Similarly, telotristat etiprate, a small-molecule tryptophan hydroxylase inhibitor, also is being considered under the FDA’s priority review program for carcinoid syndrome in patients with metastatic NETs.”

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Custirsen Combo Falls Short in Phase III mCRPC Trial

Excerpt:

“Adding custirsen to cabazitaxel (Jevtana) and prednisone in the second-line setting failed to improve overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) in the phase III AFFINITY trial, according to OncoGenex, the company developing the drug.

“The open-label AFFINITY trial included 634 men with mCRPC who progressed on docetaxel. Patients were randomized to cabazitaxel plus prednisone with or without weekly custirsen. Treatment was administered until progression, unacceptable toxicity, or the completion of 10 cycles. The study was conducted at 95 locations in North America, Europe, Russia, and Australia.”

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Final OS Analysis Confirms Cobimetinib/Vemurafenib Benefit in Melanoma

Excerpt:

“Combination therapy with cobimetinib (Cotellic) and vemurafenib (Zelboraf) reduced the risk of death by 30% compared with vemurafenib alone in patients with BRAF-positive advanced melanoma, according to the final survival analysis of the phase III coBRIM study that has now been published in The Lancet Oncology.

“The targeted combination improved median overall survival (OS) by 4.9 months versus single-agent vemurafenib (HR, 0.70; 95% CI, 0.55-0.90; P = .005). The OS rates for the combination at 1 and 2 years were 74.5% and 48.3%, respectively.

“ ‘Melanoma is one of the few cancers that has increased in incidence over the past 30 years, and until recently, people with advanced forms of the disease have had few treatment options. Five years ago, the survival of people with advanced melanoma was measured in months, and now we have medicines that are helping people live years,’ Josina Reddy, MD, PhD, senior group medical director at Genentech, the company that manufactures the combination, said in an interview with OncLive.”

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Less Treatment May Show Greater Benefit in Low-Risk Breast Cancer

Excerpt:

“Although there has been in increase in promising novel regimens available for patients with breast cancer in recent years, oncologists should carefully consider whether each agent would provide a significant enough benefit to offset its associated toxicities, cost, and the time and commitment by the patient it requires, explained Hope S. Rugo, MD.

“ ‘We have built very successful treatments that have improved survival in patients with breast cancer. The challenge we have now is to not keep adding more and more treatments as we look for better therapies to cure that group of patients who will have a recurrence,’ Rugo said during the 2016 International Congress on the Future of Breast Cancer. ‘At the same time, we also need to understand that, for the majority of patients, we are doing a pretty good job. We don’t need to add more toxicities and costs by giving them additional therapies.’ ”

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Novel Agents Emerging in Pipeline for HER2+ Breast Cancer

Excerpt:

“There have been significant advances for the treatment of HER2-positive breast cancer over the last decade, says Denise A. Yardley, MD.

“ ‘When we look at the HER2-positive patient, at this point, we have really come a long way with the initial approval of trastuzumab (Herceptin), followed by the addition of pertuzumab (Perjeta), based on the CLEOPATRA data,’ explains Yardley, senior investigator, Breast Cancer Research Program, principal investigator, Sarah Cannon Research Institute. ‘The EMILIA trial has now added T-DM1 (ado-trastuzumab emtansine; Kadcyla), a novel antibody-drug conjugate targeted against HER2.’

“While these FDA approvals have made a large impact for patients with HER2-positive breast cancer, there is still more work to be done. ‘We are really trying to extend the number of novel agents to add to the HER2-population arena,’ Yardley notes.”

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Immunotherapy/Chemo Combinations Show Potential in NSCLC

Excerpt:

“Pembrolizumab (Keytruda) and nivolumab (Opdivo) have both made a significant difference for a high number of patients with advanced non–small cell lung cancer (NSCLC). However, there is still a great deal to learn about the optimal use of PD-1 inhibitors in the disease, says Shirish Gadgeel, MD.

“ ‘Both pembrolizumab and nivolumab are approved for the management of NSCLC and have shown activity,’ says Gadgeel, medical oncologist, leader of the Thoracic Oncology Multidisciplinary Team at Karmanos Cancer Center, Wayne State University. ‘When these agents do work, the benefit is for a prolonged period of time. However, these agents are only efficacious in a minority of patients—probably in the range of 20%.’ ”

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Lead NEMO Author Shares Excitement With Binimetinib in NRAS-Mutant Melanoma

Excerpt:

“For patients with NRAS-mutant melanoma who progress following treatment with an immunotherapy agent, the MEK inhibitor binimetinib offers a promising option, explains Reinhard Georg Dummer, MD.

“Results of the open-label phase III NEMO trial, which were presented during the 2016 ASCO Annual Meeting,1 most recently demonstrated the agent’s potential. In the study, binimetinib was found to reduce the risk of progression or death by 38% when compared with dacarbazine in this subgroup of patients.

“Additionally, median progression-free survival (PFS) with binimetinib was 2.8 months versus 1.5 months with dacarbazine (HR, 0.62; 95% CI, 0.47-0.80; P <.0001). The objective response rate with binimetinib was 15%, including 1 complete response, compared with 7% for dacarbazine.”

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