Incyte Announces First Patient Treated in ECHO-301 Phase 3 Study

Excerpt:

“Incyte Corporation (INCY) today announced that the first patient has been treated in the ECHO-301 study—a Phase 3 trial evaluating epacadostat, Incyte’s investigational, highly potent and selective oral IDO1 inhibitor, in combination with Keytruda®(pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma. Incyte expects initial data from the ECHO-301 study to be available in 2018…

“ ‘We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase 3 program evaluating epacadostat in combination with pembrolizumab,’ said Steven Stein, M.D. Incyte’s Chief Medical Officer. ‘This trial—the first to test this combination in a pivotal study—is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types.’ “

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Binimetinib Improves PFS in NRAS-Mutated Metastatic Melanoma

Excerpt:

“The novel MEK inhibitor binimetinib resulted in improved progression-free survival (PFS) and response rates vs dacarbazine in patients with NRAS-mutated advanced unresectable/metastatic melanoma, according to results of an open-label phase III trial.

“ ‘NRAS mutations are present in approximately 20% of all patients with metastatic melanoma,’ said Reinhard Dummer, MD, of the University Hospital Zurich in Switzerland. ‘It activates the MAPK pathway and by this drives cell proliferation and anti-apoptotic mechanisms.’ Preclinical studies have shown that NRAS-mutant melanoma is sensitive to MEK inhibition, and binimetinib inhibits both MEK1 and MEK2. A phase II study showed clinical activity in NRAS-mutant metastatic melanoma.

“The NEMO trial included 402 patients randomized 2:1 to receive either binimetinib (269 patients) or dacarbazine (133 patients; 19 were not treated and were not evaluated for safety). Patients were either treatment-naive or had progressed on or after immunotherapy. The primary endpoint of the study was PFS. The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting held earlier this month in Chicago (abstract 9500).”

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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3-Year Follow-Up Data for Dabrafenib/Trametinib Confirm Results of Combo in Melanoma

Excerpt:

“Three-year follow-up data from the phase III COMBI-d study was presented at the 2016 ASCO Annual Meeting, revealing impressive overall survival (OS) and progression-free survival (PFS) data for the dabrafenib (Tafinlar) and trametinib (Mekinist) combination therapy for patients with BRAF-mutant metastatic melanoma.

“At the February 15, 2016 data cutoff for the 3-year analysis, 58% of patients remained on therapy. The 3-year PFS rate with the combination was 22% versus 12% with single-agent dabrafenib. The 3-year OS rate was 44% with dabrafenib plus trametinib compared with 32% with dabrafenib alone.

” ‘This is the longest OS follow-up among randomized phase III trials evaluating a BRAF plus MEK inhibitor in patients with BRAF-mutant metastatic melanoma,’ said lead investigator Keith T. Flaherty, MD, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. ‘With additional follow-up, and now 3-year maturity, dabrafenib plus trametinib continued to show significant benefit over dabrafenib monotherapy, despite crossover.’ ”

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Comparing Combination Treatments in HER2-Positive Early Breast Cancer

Excerpt:

“In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine plus pertuzumab (T-DM1+P).

“According to the results of the KRISTINE trial, the TCH+P regimen was also associated with a higher rate of breast conserving surgery. However, researchers reported that T-DM1+P had a notably better safety profile and that health-related quality of life and physical functioning were maintained longer.

“ ‘Neoadjuvant TCH+P achieved a superior pCR rate compared with T-DM1+P and was associated with a higher breast-conserving-surgery rate,’ said Sara A. Hurvitz, MD, General Internal Medicine, Hematology & Oncology, UCLA Medical Center in Santa Monica, CA. ‘However, neoadjuvant T-DM1+P had a more favorable safety profile, with lower incidence of grade 3 or greater adverse events, serious adverse events, and adverse events leading to treatment discontinuation.’ ”

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Two-Year Overall Survival Data from Two Pivotal Opdivo® (nivolumab) Trials Demonstrate Sustained Benefit In Patients with Advanced Non-Small Cell Lung Cancer

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) announced today two-year overall survival data from two pivotal Phase 3 studies evaluating Opdivo (nivolumab) versus docetaxel in previously treated metastatic non-small cell lung cancer (NSCLC). Opdivo continued to demonstrate improved overall survival (OS), the primary endpoint for both studies, at the landmark two-year time point. In CheckMate -057, a trial in previously treated non-squamous NSCLC, 29% of patients treated with Opdivo were alive at two years (n=81/292) versus 16% of those treated with docetaxel (n=45/290) (HR: 0.75 [95% CI: 0.63, 0.91]). In CheckMate -017, a trial in previously treated squamous NSCLC, 23% of patients treated withOpdivo were alive at two years (n=29/135) versus 8% of those treated with docetaxel (n=11/137) (HR: 0.62 [95% CI: 0.47, 0.80]). In Checkmate -057 and -017, treatment-related adverse events (AEs) occurred in 71% and 61% of Opdivo-treated patients. The safety profile of Opdivo at two years was consistent with previous reports of data from both studies.”

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Advanced Breast Cancer Slowed with Avastin Combo (CME/CE)

Excerpt:

“Adding bevacizumab (Avastin) to letrozole (Femara) improved progression-free survival (PFS) in estrogen receptor-positive metastatic breast cancer (ER+MBC) but not other outcomes, an open-label, multicenter phase III trial showed.

“While median PFS increased by 4.6 months in patients who received combined therapy versus letrozole alone, there was no significant difference in overall survival (hazard ratio 0.87; 95% CI 0.65-1.18; P=0.188), Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported online in the Journal of Clinical Oncology.

“In addition, there was a marked increase in grade 3 to 4 toxicities, particularly hypertension (24% versus 2%) and proteinuria (11% versus 0%), the researchers said, emphasizing that the role of bevacizumab in this setting will need to be clarified with research on predictive markers.”

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MammaPrint Genetic Test Can Reduce Use of Post-surgery Chemotherapy Among Early-stage Breast Cancer Patients

Excerpt:

“Among patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria, the MammaPrint genetic test identified a large group of patients for whom five-year distant metastasis–free survival was equally good whether or not they received adjuvant chemotherapy (chemotherapy given post-surgery), according to results from the randomized, phase III microarray in node negative disease may avoid chemotherapy (MINDACT) clinical trial to be presented here at the AACR Annual Meeting 2016, April 16-20.”

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Patients With EGFR Expressing NSCLC Benefit Most From Necitumumab Added to Chemotherapy

Excerpt:

“Patients with epidermal growth factor receptor (EGFR) expressing advanced squamous non-small-cell lung cancer benefit most from necitumumab added to gemcitabine and cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.

“The randomised phase III SQUIRE trial demonstrated that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved overall survival in patients with stage IV squamous  by 1.6 months compared to chemotherapy alone. The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.”

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