Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma

“Array BioPharma (Nasdaq: ARRY) today reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial.  The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.”


Phase III BELLE-2 Trial Meets Primary Endpoint of Progression-free Survival

“Among women with locally advanced or metastatic hormone receptor-positive breast cancer that was resistant to hormone therapy, those who had mutated PIK3CA detected in their blood benefited from a combination of the investigational PI3K inhibitor buparlisib and fulvestrant, according to data from the phase III BELLE-2 trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“ ‘BELLE-2 is a randomized, phase III clinical trial designed to assess the efficacy of the investigational PI3K inhibitor buparlisib in combination with fulvestrant in breast cancer patients whose tumors no longer respond to aromatase inhibitors,’ said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.”


Immunomedics Reports Improved Progression-Free Survival Results With Sacituzumab Govitecan in Triple-Negative Breast Cancer

“Immunomedics, Inc. (Nasdaq: IMMU) today announced that patients with metastatic triple-negative breast cancer (TNBC) lived for a median of seven months without tumor progression, after receiving at least 3 doses of sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC) for solid cancer therapy, in a Phase 2 clinical study. The study also indicated that the responses were very durable, showing a median time-to-progression, based on computed tomography, of 9.4 months (range of 1.8+ to 13.2+ months), which included patients with stable disease, and partial and complete responses.

” ‘Patients in this late-stage setting usually have a median PFS of three to four months when treated with other agents,’ stated Aditya Bardia, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, Attending Physician at the Massachusetts General Hospital Cancer Center in Boston, and an investigator in this trial. ‘Sacituzumab govitecan is a promising agent that offers hope for these patients with poor prognosis,’ Dr. Bardia added.”


FDA Grants Priority Review of Opdivo plus Yervoy in Previously Untreated Advanced Melanoma

“The FDA has accepted a supplemental biologics license application for the Opdivo plus Yervoy regimen to include data from a phase 3 trial of patients with previously untreated advanced melanoma, according to a press release from Bristol-Myers Squibb.

“The agency also granted priority review of the application, with a target action date of Jan. 23, according to the release

” ‘Findings from CheckMate -067 provide additional evidence that the combination of the two immuno-oncology agents, Opdivo [nivolumab] and Yervoy [ipilimumab], may provide improved outcomes for patients with advanced melanoma, and has the potential to become the basis of how this devastating disease is treated,’ Michael Giordano, senior vice president, head of development for oncology at Bristol-Myers Squibb, said in a press release. ‘We saw significant clinical benefit from the Opdivo+Yervoy regimen in these patients, including an increase in the time patients lived without disease progression, and we look forward to working with the FDA to review this data.’ “


Arteries Better than Veins for Liquid Biopsy

“As the field of liquid biopsies for tracking disease progression and therapeutic response heats up, many doctors are looking for ways to apply this approach to their patients. Currently, assays for circulating tumor cells (CTCs) – one type of liquid biopsy – have been approved for diagnostic purposes in metastatic breast, colorectal, or prostate cancer. In these diseases, the presence of CTCs in the peripheral blood is associated with decreased progression-free survival and decreased overall survival. The major challenge for this technology is that CTCs are not always found in the blood of patients with aggressive disease who would be expected to have high numbers. Now, researchers at Thomas Jefferson University investigating uveal melanoma, a type of melanoma that originates in the eye, have shown that the low numbers could simply be explained by where the blood is drawn – whether from a vein or an artery.”


Everolimus Improves Progression-Free Survival for Patients with Advanced, Nonfuctional Neuroendocrine Tumors

“In an international Phase III randomized study, everolimus, an inhibitor of the mammalian target of rapamycin (mTOR), has shown to dramatically improve progression-free survival for patients with advanced, nonfunctional neuroendocrine tumors (NET) of the lung and gastrointestinal tract.

“James C. Yao, M.D., professor and chair, The University of Texas MD Anderson Cancer Center’s Department of Gastrointestinal Medical Oncology, presented the findings today in Vienna, Austria during the presidential session of the European Cancer Congress, co-sponsored by the European Cancer Organisation and European Society for Medical Oncology.

“NETs develop from cells in the neuroendocrine system, which is responsible for producing specific hormones that regulate the functions of different organs in the body. NETs can be slow-growing or aggressive, and are found most commonly in the lungs or gastrointestinal system. Nonfuctional NETs are those that do not secrete a hormone. About 80 percent of all NETs are nonfunctional, and therefore, patients often have few side effects and are diagnosed later, explains Yao.”


Rare Cancer Responds Unusually Well to New Treatment

“Vienna, Austria: Patients with advanced gastrointestinal neuroendocrine tumours (NETs) have limited treatment options and there are few oncologists who are specialised in this relatively rare disease. But now results from a multi-centre randomised international trial of an innovative treatment show a marked improvement in the length of time patients with mid-gut NETs live without the disease getting worse (progression-free survival, or PFS), researchers will report to the 2015 European Cancer Congress today.

“Professor Philippe Ruszniewski, MD, Head of the Department of Gastroenterology-Pancreatology, Beaujon Hospital, Clichy, France, who is also a Professor at Paris Diderot University, will tell the Congress that results of the NETTER-1 phase III trial of 177Lu-DOTATATE (Lutathera) show a PFS that has never been shown before in this type of cancer. “Because these patients have a real unmet medical need, this is particularly pleasing for us,” he says.

“Lutathera is a member of the family of novel treatments called Peptide Receptor Radionuclide Therapy (PRRTs) which involve targeting tumours with radiolabelled somatostatin analogue (SSA) peptides. The technique belongs to the larger family of molecular nuclear medicine, where trace amounts of active substances, or radiopharmaceuticals, are used to create images and to treat various diseases including cancer. SSAs are widely used in gastrointestinal NETs cancer to reduce symptoms such as diarrhoea.”


Drug Combination Improves Progression-Free Survival in Melanoma Patients

“Patients with advanced melanoma skin cancer survive for longer without their disease progressing if they have been treated with a combination of two drugs, nivolumab and ipilimumab, than with either of these drugs alone. New results show that these patients also do better regardless of their age, stage of disease and whether or not they have a cancer-driving mutation in the BRAF gene.

“Dr James Larkin, a Consultant Medical Oncologist at The Royal Marsden, London, UK, told the 2015 European Cancer Congress, that results from the CheckMate 067 phase III clinical trial had already shown that the combination of the two drugs, which target two different pathways that regulate the immune system, improved the progression-free survival in patients with melanoma who had not received any other treatment. However, until now it was not known whether this remained the case when the results were analysed according to genetic status, age and how advanced was their disease.

“Nivolumab is an inhibitor of the protein 1 (known as PD-1), which functions as an immune checkpoint, playing an important role in the immune system. Ipilimumab inhibits the CTLA-4 checkpoint, which also plays a role in the immune system.”


No Benefit of Adding Gefitinib to Platinum-Based Doublet in EGFR-Mutant NSCLC After Progression on First-Line Gefitinib

“In a phase III IMPRESS trial reported in The Lancet Oncology, Soria et al found no progression-free survival benefit of adding gefitinib (Iressa) to platinum-based doublet chemotherapy in patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC) who had acquired resistance to first-line gefitinib.

“In the double-blind trial, 265 chemotherapy-naive patients from 11 countries who had stage IIIB to IV EGFR-mutant disease and disease control with first-line gefitinib and recent disease progression took part. They were randomly assigned between March 2012 and December 2013 to receive cisplatin 75 mg/m2 plus pemetrexed (Alimta) 500 mg/m2 on the first day of a maximum of six chemotherapy cycles plus either daily gefitinib 250 mg (n = 133) or placebo (n = 132) continued until disease progression or discontinuation for other reasons…

“The investigators concluded: ‘Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment. Platinum-based doublet chemotherapy remains the standard of care in this setting.’ ”