Merrimack Presents Expanded Analysis from Seribantumab (MM-121) Phase 2 Breast Cancer Study at the AACR Precision Medicine Series

Excerpt:

“Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today presented an expanded analysis of its Phase 2 study of seribantumab (MM-121) in combination with exemestane in HER2-negative, hormone receptor positive metastatic breast cancer.  Top line results from this study were announced in 2014. The final analysis, as well as a poster on Merrimack’s investigational companion diagnostic for seribantumab, were presented this week at the AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer, in Miami, Florida.

” ‘This data package underscores the most significant finding from all of our seribantumab Phase 2 studies – the identification of a heregulin-positive cancer cell phenotype that infiltrates approximately 30-50% of tumors and that may directly impact response to current standard-of-care therapies.  This hypothesis is supported by a strong consistent data set that spans three solid tumor types where we saw improved progression free survival when seribantumab was added to each of the standard-of-care regimens,’ saidAkos Czibere, MD, Ph.D., Senior Medical Director and Team Lead for the seribantumab program. ‘We are currently pursuing a registration study for seribantumab in patients with non-small cell lung cancer whose disease has progressed following immunotherapy.’ ”

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Long-Term Survival Achieved in Metastatic Melanoma With Personalized Vaccine

Excerpt:

“Two patients with melanoma that had spread to the liver survived for at least 8.5 and 12 years after resection of the hepatic tumor and treatment with patient-specific immunotherapeutic vaccines. The vaccines, designed to activate the immune system against the tumor, were derived from the patients’ own dendritic cells loaded with proteins isolated from their tumors, as described in an article published in Cancer Biotherapy and Radiopharmaceuticals.

“Robert O. Dillman, MD, formerly Vice President Oncology, Caladrius Biosciences, Inc. and currently Chief Medical Officer, NeoStem Oncology (Irvine, CA) and Executive Medical and Scientific Director, Hoag Cancer Institute (Newport Beach, CA) discusses the typically poor prognosis for patients with melanoma of the eye or skin that spreads to the liver, and reports on the potential to achieve long-term survival without disease progression in a subset of patients using the eltrapuldencel-T vaccine. One patient had no disease progression for more than 4.5 years, while the other patient survived and remained disease-free for more than 12 years.”

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CHMP Recommends EU Approval for Roche's Avastin in Combination With Tarceva for Patients With a Specific Type of Advanced Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.”

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Dabrafenib Active in BRAF-Mutant Metastatic NSCLC

Excerpt:

“Planchard et al found that the BRAF kinase inhibitor dabrafenib (Tafinlar) produced responses in previously treated and untreated patients with BRAF-mutant metastatic non–small cell lung cancer (NSCLC), according to a phase II trial reported in The Lancet Oncology. Activating BRAF V600E mutations are found in approximately 1% to 2% of lung adenocarcinomas.”

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Steroid Use With Abiraterone Offers Multidimensional Benefits to Patients With mCRPC

Excerpt:

“For decades, the standard of care for men with advanced prostate cancer has been the depletion or inhibition of androgens. While androgen-deprivation therapy (ADT) often results in temporary tumor regression or symptom relief in some patients, disease progression ultimately occurs over time. For patients with metastatic disease, the median overall survival (OS), until very recently, had been less than 2 years after chemotherapy.

“While tumor progression with ADT was previously believed to be hormone-refractory or androgen-independent, a large body of evidence supports that metastatic castration-resistant prostate cancer (mCRPC) is commonly driven by elevated steroid synthesis, increased expression or splice variants of the androgen receptor (AR), or AR ligand promiscuity, indicating the ongoing need for targeted androgen therapies.”

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Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Breast Cancer

Excerpt:

“While neratinib plus paclitaxel was not superior to trastuzumab plus paclitaxel as first-line treatment for ERBB2-positive metastatic breast cancer in terms of progression-free survival, the combination was associated with delayed onset and reduced frequency of central nervous system metastases, a finding that requires a larger study to confirm, according to an article published online by JAMA Oncology.

“Metastatic ERBB2-positive breast cancer has a characteristic spread with most patients developing liver metastases and about half having poor prognosis with central nervous system involvement.

“Ahmad Awada, M.D., of the Jules Bordet Institute, Brussels, and coauthors conducted a randomized clinical trial to examine progression-free survival in women with recurrent or metastatic ERBB2-positive breast cancer. They also examined secondary outcomes that included time to symptomatic or progressive central nervous system lesions and safety.”

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TDM-1 With Docetaxel/Pertuzumab Offers Benefit in Advanced HER2-Positive Breast Cancer

Excerpt:

“Combining trastuzumab emtansine with docetaxel both with and without pertuzumab yielded promising efficacy in a phase Ib/IIa study of patients with HER2-positive locally advanced (LABC) or metastatic breast cancer (MBC). Many patients, however, required dose reductions due to toxicity.

“Trastuzumab emtansine (T-DM1) is a drug-antibody conjugate, and has been shown to offer significant survival benefits in phase III trials of HER2-positive metastatic breast cancer. ‘In preclinical studies, T-DM1 exhibited enhanced antitumor activity when combined with docetaxel or pertuzumab,’ wrote study authors led by Miguel Martin, MD, PhD, of Hospital General Universitario Gregorio Marañón in Madrid.”

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EU Expands Nivolumab Approval for Lung and Kidney Cancer

Excerpt:

“The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).

“The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.

“Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.”

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Crizotinib Tops Chemo for ALK-Positive NSCLC With Brain Metastases

Excerpt:

“First-line crizotinib therapy offered better intracranial disease control rate (IC-DCR) than chemotherapy in patients with ALK-positive non–small-cell lung cancer (NSCLC) and stable treated brain metastases, according to results of a phase III study.

“Earlier results from the ongoing PROFILE 1014 trial showed that crizotinib offers better progression-free survival (PFS) and response rates compared with pemetrexed-platinum chemotherapy. ‘Although the development of targeted therapies has improved outcomes for selected patient populations with oncogenic driver mutations, brain metastases are frequent and result in significant morbidity and mortality in patients with lung cancer,’ wrote study authors led by Benjamin J. Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in East Melbourne, Australia.”

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