Bristol-Myers' Opdivo Fails Lung Cancer Trial; Shares Plunge

Excerpt:

“Bristol-Myers Squibb Co said its blockbuster Opdivo immunotherapy failed to slow progression of symptoms in previously untreated patients with advanced lung cancer, a major setback expected to benefit Merck & Co’s rival medicine.

“Shares of Bristol-Myers fell almost 16 percent to $63.54 on Friday after the company announced failure of the late-stage trial. Shares of Merck gained 8.7 percent to $62.89.

” ‘This is the worst-case scenario’ for Opdivo and Bristol-Myers, Leerink analyst Seamus Fernandez said in a research note. ‘There appears to be no silver lining.’ ”

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Cobimetinib, Vemurafenib Improved Survival in BRAF V600–Mutated Melanoma

Excerpt:

“Combination treatment with cobimetinib and vemurafenib resulted in significantly improved overall and progression-free survival in patients with previously untreated BRAF V600mutated advanced melanoma, according to updated efficacy results of the coBRIM trial published in Lancet Oncology.

“ ‘Patients treated with the combination of cobimetinib and vemurafenib achieved a higher objective response, longer progression-free survival, and longer overall survival compared with patients treated with vemurafenib alone,’ wrote researchers led by Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori Fondazione G Pascale in Naples, Italy. ‘The combination of cobimetinib and vemurafenib was recently approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of advanced BRAF V600mutant melanoma and represents a new standard of treatment for patients with this disease.’ ”

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African-American Men Negatively Impacted by Hormone Therapy for Treatment of Prostate Cancer

Excerpt:

“In a retrospective study analyzing patients’ medical records, researchers at Brigham and Women’s Hospital found that patients’ race significantly affected their longevity by increasing the likelihood of death after receiving androgen deprivation therapy (ADT). ADT was used to reduce the size of the prostate to make a patient eligible for prostate brachytherapy. These findings are published in the August 4, 2016 issue of Cancer.

“Konstantin Kovtun, MD, a resident at BWH, Anthony D’Amico, MD, PhD, chief of Genitourinary Radiation Oncology at BWH, and colleagues, analyzed the medical records of over 7000 men from the Chicago Prostate Cancer Center who had low or favorable-intermediate risk prostate cancer, 20 percent of whom were treated with ADT in order to reduce the size of their prostate gland to make them eligible for brachytherapy. They found that African-American men who were treated with ADT had a 77 percent higher risk of death when compared to non-African American men, the causes of which were not due to prostate cancer.”

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Addition of Bevacizumab Shows No Survival Advantage Over Cisplatin Pemetrexed Alone in Non-Squamous NSCLC

Excerpt:

“Preliminary data from the SAKK19/09 trial shows no overall survival difference between two cohorts of patients with non-squamous non-small cell lung cancer (NSCLC) receiving similar cisplatin pemetrexed-based regimens.

“The SAKK19/09 trial examined a total of 77 patients with EGFR wild type non-squamous NSCLC. Both cohorts received cisplatin pemetrexed in the frontline, while one cohort had the addition of bevacizumab. In an interview with Targeted Oncology, Oliver Gautschi, MD, Assistant Professor, University of Bern, President, SAKK Lung Cancer Group, discusses the lack of differences in overall survival, where the field is going as a whole, and why combination maintenance therapy is not better than a single agent.”

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Marine Drug Goes to Phase III Trials to Treat Lung Cancer

Excerpt:

“PharmaMar is starting a new Phase III trial, with patients suffering from small cell lung cancer (SCLC). It’ll test the efficacy of its third candidate obtained from marine organisms (PM1183) as a SCLC treatment.

“PharmaMar is one of the hot Biotechs in Spain, which just saw its second drug finish Phase III trials with good results (and is already in trials for other indications, as we’ve seen at ASCO).

“Now, PM1183 is under the spotlight. This cancer drug will be used in a second Phase III trial (after ovarian cancer). It’ll enrol 600 patients with small cell lung cancer (SCLC), for whom platinum-based treatments have failed before.”

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Targeted Therapies Beneficial in KRAS-Mutated NSCLC

Excerpt:

“Targeted therapies that do not contain erlotinib can be beneficial for patients with KRAS-mutated (KRAS mut+) advanced non-small-cell lung cancer (NSCLC), according to a study published online Aug. 1 in the Journal of Clinical Oncology.

“Vassiliki Papadimitrakopoulou, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined the effects of targeted therapies in NSCLC. Patients were randomized to four arms: erlotinib (22 patients), erlotinib plus MK-2206 (42 patients), MK-2206 plus AZD6244 (75 patients), or sorafenib (61 patients).

“The researchers found that the primary end point of an eight-week disease control rate (DCR) was 48 percent in all 186 evaluable patients (32, 50, 53, and 46 percent, respectively, for the four treatment arms). For the 27 percent of patients who were KRAS mut+, DCR was 20, 25, 62, and 44 percent, respectively, compared with 36, 57, 49, and 47 percent, respectively, for KRAS wild-type patients. Median progression-free survival was 2.0 months: 1.8 and 2.5 months for arms 1/2 and 3/4, respectively, in KRAS mut+ patients (P = 0.04). In KRAS wild-type patients, median overall survival was 6.5 months: 9.0 and 5.1 months in arms 1/2 and 3/4, respectively (P = 0.03).”

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US Breakthrough Status for Novartis' Breast Cancer Drug

Excerpt:

“Novartis’ experimental selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has picked up a Breakthrough Therapy designation in the US for the treatment of certain forms of breast cancer.

“The drug is being developed for use alongside letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

“The award indicates the US Food and Drug Administration’s belief that LEE011 could potentially offer an improvement over an available therapy on at least one clinically significant endpoint, and is designed to help speed up its regulatory pathway to ensure quicker access for patients.”

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Use of Anthracyclines Plus Taxanes Found to be Beneficial in Early, HER2-Negative Breast Cancer

Excerpt:

“Treatment with anthracyclines was proven to be beneficial for patients with high-risk, HER2-negative, early-stage breast cancer, according to a joint analysis of the “ABC” trials presented at the 2016 ASCO Annual Meeting.

“The analysis, which included more than 4000 patients, demonstrated that docetaxel plus cyclophosphamide (TC) was significantly inferior to various taxane-plus-anthracycline-based (TaxAC) chemotherapy regimens.

“ ‘Statistical noninferiority of the non-anthracycline regimen could not be demonstrated,’ said lead investigator Joanne Lorraine Blum, MD, PhD, medical oncologist with Texas Oncology at the Baylor-Sammons Cancer Center in Dallas. ‘In terms of the study’s primary endpoint, invasive disease-free survival, TC x 6 was significantly inferior to TaxAC.’ ”

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Cancer Surgeons Advise Against Removal of Healthy Breast

Excerpt:

“Only certain women with cancer in one breast should have their healthy breast removed in an attempt to prevent cancer, a leading group of breast surgeons maintains.

“The new position statement from the American Society of Breast Surgeons comes at a time when more breast cancer patients are asking doctors to remove the unaffected breast — a procedure known as contralateral prophylactic mastectomy.

” ‘Contralateral prophylactic mastectomy is a growing trend that has generated significant discussion among physicians, patients, breast cancer advocates and media,’ said position statement lead author Dr. Judy Boughey. She is professor of surgery at Mayo Clinic in Rochester, Minn.”

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