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Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

On May 6, 2014 Merck & Co reported that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck’s investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab (Press release Merck & Co, MAY 6, 2014, View Source [SID:1234500607]). The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA’s Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.

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Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.

"Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options."

10-Q – Quarterly report [Sections 13 or 15(d)]

AMAG Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , AMAG Pharmaceuticals, MAY 5, 2014, View Source [SID1234500484]).

Pfizer Reports First-Quarter 2014 Results

For women treated with the combination of palbociclib plus letrozole, the median PFS was 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who received letrozole alone (HR=0.488 [95% CI: 0.319, 0.748]; p=0.0004) (Press release Pfizer, MAY 5, 2014, View Source [SID:1234500490]). Final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate demonstrated superiority in the palbociclib plus letrozole arm compared to the letrozole-only arm. Additionally, an initial assessment of overall survival (OS), a secondary endpoint, was performed. Based on the events accrued at the time of final PFS analysis, a median OS of 37.5 months was observed in the combination arm versus 33.3 months for those who received letrozole alone, a difference of 4.2 months (HR=0.813, 95% CI: 0.492, 1.345), which was not statistically significant. A follow-up OS analysis will be conducted following the accrual of additional events. The combination of palbociclib and letrozole was generally well-tolerated and the safety profile of the combination was consistent with previously reported data. Pfizer continues to work with the FDA and other regulatory authorities to define the appropriate regulatory path forward for palbociclib.

Novartis drug Signifor® LAR shows superior efficacy in acromegaly patients not controlled on first generation somatostatin analogues

On May 5, 2014 Novartis reported results from a pivotal Phase III trial of investigational therapy Signifor LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control (Press release Novartis, MAY 5, 2014, View Source [SID:1234500489]). The study findings showed that patients taking pasireotide long-acting release (LAR) achieved greater disease control when compared to continued treatment with the standard somatostatin analogue therapies, octreotide LAR or lanreotide Autogel.
This study evaluated pasireotide LAR 40 mg and 60 mg against continued therapy with octreotide LAR or lanreotide Autogel in patients who did not achieve GH and IGF-1 biochemical control despite receiving the maximum approved doses of these currently available somatostatin analogues (SSAs). In the trial, significantly more patients achieved biochemical control with each dose of pasireotide LAR compared to the octreotide LAR and lanreotide Autogel control arm. Specifically, 15.4% and 20.0% of those with inadequately controlled acromegaly taking pasireotide LAR 40 mg and 60 mg, respectively (95% confidence interval [CI], 7.6-26.5; P=0.0006; 95% CI, 11.1-31.8; P<0.0001), achieved biochemical control versus 0% achieving biochemical control on continued treatment with octreotide LAR or lanreotide Autogel (95% CI, 0-5.3). The incidence and severity of adverse events (AEs) was similar across all treatment groups, except for a higher frequency and degree of hyperglycemia in the pasireotide LAR arm. Worldwide regulatory filings for pasireotide LAR in acromegaly are currently underway based on these results and separate previously published robust Phase III data.

MEI Pharma Initiates Clinical Study Of Mitochondrial Inhibitor Drug Candidate ME-344 In Small Cell Lung And Ovarian Cancers

On May 5, 2014 MEI Pharma reported that the first patient has been dosed in a Phase Ib clinical study (NCT02100007) of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin (topotecan) in patients with solid tumors, including small cell lung and ovarian cancers. The open-label study is expected to enroll up to 64 patients with preliminary data anticipated by the first quarter of 2015 (Press release MEI Pharma, MAY 5, 2014, View Source [SID:1234500487]).
In October 2013, results from a Phase I clinical study of ME-344 were announced showing preliminary evidence of single-agent activity in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. Notably, one patient with small cell lung cancer achieved a confirmed partial response (PR) and still remains on study after more than 89 weeks. ME-344 was generally well tolerated in the study at doses equal to or less than 10 mg/kg delivered on a weekly schedule for extended durations. Dose limiting toxicities were observed at both the 15 and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy.
The Phase Ib study now underway is evaluating the safety and tolerability of intravenous ME-344 in combination with Hycamtin, a chemotherapy approved by the U.S. Food & Drug Administration for the treatment of small cell lung, ovarian and cervical cancers. The initial stage of the study will establish the maximum tolerated dose (MTD) of ME-344 in combination with Hycamtin in up to 24 patients. Once the MTD has been determined, the study will enroll an additional 40 patients into two cohorts: relapsed/refractory small cell lung cancer and platinum-refractory ovarian cancer.
The open-label study is being conducted in collaboration with the Sarah Cannon Research Institute at the University of Oklahoma in Oklahoma City and Tennessee Oncology in Nashville.