Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”


Promising Drug Combination for Advanced Prostate Cancer

“A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.

” ‘We hope to find a well-tolerated and effective treatment to slow the progression of prostate cancer in men with advanced prostate cancer. The approach combines several drugs and attacks the cancer on several fronts,’ said Dr. Fred Saad, researcher at the University of Montreal Hospital Research Centre (CRCHUM) and principal investigator of the study.

“Antonio Paris, 59, is one of the patients participating in the CRCHUM. “Since I started the new treatment 14 months ago, my cancer first remitted and now is stable,” he said.”


HER2-Enriched Molecular Subgroup Highly Sensitive to Breast Cancer Regimens

“The primary analysis of the phase III CALGB 40601 trial found that pathologic complete response (pCR) to dual HER2 blockade was not statistically higher than anti-HER2 monotherapy. However, there was a high level of intertumoral heterogeneity, and patients with the HER2-enriched subtype had a high pCR with both single and dual anti-HER2 therapy, according to data recently published in the Journal of Clinical Oncology.

“ ‘This trial paves the way for integrating molecular analyses into other trials in HER2-positive breast cancer, and may allow us to take a less-is-more approach for women who are selected to be highly sensitive to targeted treatments and to have a good prognosis,’ said lead study author Lisa Carey, MD, a UNC Lineberger member, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research at the University of North Carolina School of Medicine, and the physician-in-chief of the North Carolina Cancer Hospital, in a statement.”


Dual HER2 Blockade Fails to Improve Response Rate in HER2-Positive Breast Cancer

“Dual HER2 blockade with trastuzumab and lapatinib was no better than trastuzumab alone in producing pathologic complete responses (pCR) in metastatic HER2-positive breast cancer patients in the neoadjuvant setting, according to a new study. Those with hormone receptor–negative disease did see an improvement with the dual blockade.

“ ‘In randomized neoadjuvant trials, dual HER2 targeting generally results in higher pCR rates, but the magnitude of this effect has varied,’ wrote study authors led by Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill. The new trial was a three-arm study of preoperative therapy in 305 patients with stage II/III HER2-positive breast cancer; 118 patients were randomized to paclitaxel along with trastuzumab and lapatinib, 120 to paclitaxel with trastuzumab alone, and another 67 to paclitaxel along with only lapatinib. That last trial arm was closed early. Results were published online ahead of print in the Journal of Clinical Oncology.”


Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for Yervoy (ipilimumab) as Adjuvant Treatment for Fully Resected Stage III Melanoma

Bristol-Myers Squibb Company BMY, -0.27% today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% ci:19)(95% ci:39) for Yervoy vs. 17 months (95% ci:13)(95% ci:22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm).”


Merck's Keytruda Extends Survival in Lung Cancer Study

“Merck & Co’s approved Keytruda lung cancer treatment provided superior overall survival to chemotherapy in a late-stage study of patients with advanced disease whose tumors produce a protein called PD-L1 associated with increased risk of the disease.

“The U.S. drugmaker on Monday said patients taking the approved 2 milligram dosage of Keytruda and those taking an experimental 10 milligram dose had longer overall survival compared with those taking docetaxel, a standard treatment for non small cell lung cancer (NSCLC), the most common form of lung cancer. Keytruda thereby met its main goal of the study.

“Patients whose tumors had especially high levels of PD-L1 also went longer without a progression of disease than those taking docetaxel, Merck said. Those whose tumors expressed PD-L1, but not at high levels, did not show such a statistically significant benefit in progression-free survival.”


CRT May Be Preferred Strategy for Elderly with Lung Cancer

“Chemoradiotherapy (CRT) is associated with survival benefit over chemotherapy (CT) alone for elderly patients with limited-stage small-cell lung cancer, according to a study published online Oct. 19 in the Journal of Clinical Oncology.

“Christopher D. Corso, M.D., Ph.D., from the Yale University School of Medicine in New Haven, Conn., and colleagues examined outcomes for elderly patients (≥70 years) treated with CT versus CRT. Data were included for 8,637 patients with limited-stage small-cell lung  in the National Cancer Data Base between 2003 and 2011.

“The researchers found that 43.7 and 56.3 percent of the patients received CT and CRT, respectively. CRT receipt was less likely with increasing age, clinical stage III disease, female sex, and the presence of medical comorbidities (all P < 0.01). Compared with CT, CRT use correlated with increased overall survival on univariate and multivariate analysis (median overall survival, 15.6 versus 9.3 months). Survival benefit associated with CRT was confirmed in a propensity score-matched cohort of 6,856 patients (hazard ratio, 0.52; P < 0.001). In subset analysis, patients who were alive at four months after diagnosis had a  with concurrent versus sequential CRT (median overall survival, 17.0 versus 15.4 months; log-rank P = 0.01).”


FDA Grants Priority Review to Rociletinib for Advanced NSCLC

“The FDA granted priority review to a new drug application for rociletinib.

“Rociletinib (Clovis Oncology) — a novel, oral, targeted covalent mutant-selective epidermal growth factor receptor inhibitor — is intended for patients with advanced EGFR-mutant, T790M-positive non–small cell lung cancer who already received EGFR-targeted therapy.

“The FDA is expected to make a decision about the agent’s status by March 30, 2016.”


JUNIPER Trial Branches Out in KRAS Mutation-Positive Advanced NSCLC

“In 2008 Linardou et al published results of a meta-analysis of studies in advanced non–small cell lung cancer (NSCLC) and metastatic colorectal cancer. They extracted data on 1008 patients; 165 from 17 manuscripts for the NSCLC portion of the meta-analysis had KRAS mutations. They sought to establish whether or not KRAS mutations could be candidate predictive biomarkers for antiepidermal growth factor (EGFR) treatments. The analysis yielded empirical evidence that KRAS mutations are highly specific negative predictors of response to EGFR tyrosine kinase inhibitors (TKIs) when given as single agents to patients with advanced NSCLC. Further implicating an association of KRAS mutations with poor outcomes, a retrospective analysis of data from 1036 patients with stage IV lung adenocarcinoma and KRAS mutation evaluated between 2002 and 2009, found the presence of KRAS mutations to be associated with shorter survival (HR, 1.21; P = .48).”