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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ASCO: Combo Tx Fails in Local High-Risk Prostate Ca

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“Neoadjuvant enzalutamide (ENZA) and abiraterone acetate (AA) plus 5 mg prednisone daily can be given safely for 6 months in men with localized high-risk prostate cancer prior to prostatectomy, a neoadjuvant study showed.

“However, the findings did not favor adding ENZA to augment AA plus leuprolide acetate (LHRHa) efficacy in localized high-risk prostate cancer, Eleni Efstathiou, MD, PhD, of the University of Texas MD Anderson Cancer Center, in Houston, said during a presentation at the American Society of Clinical Oncology.

“Pathologic downstaging (≤ pT2N0) occurred in 30% of patients treated with the combination therapy (AA+ENZA+ LHRHa) versus 52% of patients who received AA plus LHRHa alone (P=0.07), the study showed. Despite universal PSA depletion (≤ 0.1), a wide range of viable tumor was observed (volume 0-8.64 cc, cellularity 0-90%, and a tumor epithelial volume [TEV] 0-5.58 cc). TEV and stage were aligned.”

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ASCO 2016: Nivolumab Alone or in Combination With Ipilimumab Active in Recurrent Small Cell Lung Cancer

Excerpt:

“A study presented by Antonia et al at the 2016 ASCO Annual Meeting (Abstract 100) showed that utilizing the immunotherapeutic agents nivolumab (Opdivo) and ipilimumab (Yervoy) could lead to more effective treatment options for patients with small cell lung cancer (SCLC) who have progressed after prior chemotherapy.

“Studies have shown that nivolumab combined with ipilimumab results in improved antitumor activity when compared with either agent alone. The U.S. Food and Drug Administration recently approved this two-drug combination for the treatment of advanced melanoma.

“Given the promising activity of the immunotherapy combination in melanoma, researchers wanted to assess whether this regimen could also be effective in other types of tumors with few to no therapeutic options.”

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New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from an initial proof-of-concept study of KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, combined with standard treatments, one with bevacizumab and others without, in non-small cell lung cancer (NSCLC) including chemotherapy in previously untreated patients with NSCLC; the study showed overall response rates (ORR) ranging from 48 to 71 percent, depending on the therapy used. These data, from the phase 1/2 KEYNOTE-021 trial, will be presented today at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Shirish Gadgeel of the Barbara Ann Karmanos Cancer Institute (Abstract #9016) from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 3:00 – 4:15 p.m. CDT (Location: E354b).

“ ‘Combining KEYTRUDA and chemotherapy in the first-line lung cancer treatment setting is an important part of our effort to develop more treatment options for patients with non-small cell lung cancer,’ said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. ‘This study has helped us to identify chemotherapy options for combination with KEYTRUDA regardless of PD-L1 expression to take forward in phase 3 trials.’ ”

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Combining Radiation With Immunotherapy Showing Promise Against Melanoma

Excerpt:

“Combining radiation treatments with a new generation of immunotherapies is showing promise as a one-two-punch against melanoma, Loyola Medicine researchers report in the Journal of Radiation Oncology.

“Radiation kills cancer cells by damaging their DNA. Immunotherapies work by harnessing a patient’s immune system to attack and kill cancer cells. When combined, the two therapies appear to have synergistic effects, according to the article by James S. Welsh, MD and colleagues.

“Dr. Welsh is a professor in the department of radiation oncology of Loyola University Chicago Stritch School of Medicine.”

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Video: Dr. Ribas on Triplet Regimens in Melanoma

Excerpt:

“Antoni Ribas, MD, PhD, professor of Hematology and Oncology and director of the Tumor Immunology Program Area at UCLA Jonsson Comprehensive Cancer Center, discusses triplet therapies for patients with melanoma and the sequencing challenges associated with the approvals of additional agents in the field.

“Though current immunotherapy regimens are showing significant activity in patients, Ribas says the response rate is not 100%; therefore, there needs to be investigations of other ways to modulate the immune system. Patients who benefit from PD-1 monotherapy should not receive any more, as it will lessen treatment-related toxicities, he adds.”

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Melanoma Combinations: Going Beyond Ipilimumab/Nivolumab

Excerpt:

“Ipilimumab (Yervoy) and nivolumab (Opdivo) may be getting plenty of buzz; however, the dual immunotherapy regimen is certainly not the only combination making a significant impact in the treatment of patients with advanced melanoma, explains Omid Hamid, MD.

“ ‘On the heels of the ipilimumab/nivolumab combination having such a high response rate and while we are still awaiting survival data, we have been looking to find other standard combinations for advanced melanoma,’ says Hamid, chief of Translational Research and Immunotherapy, director of Melanoma Therapeutics, The Angeles Clinic. ‘That is not to say that ipilimumab/nivolumab is not a standard; it is a breakthrough in showing that we can combine these types of agents and have good outcomes. However, it makes a lot of sense to look at these other combinations.’ ”

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Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) for Treatment of Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).”

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Cancer Immunotherapies and Radiation Form Powerful Combination Therapy, Researchers Say

Excerpt:

“Cancer immunotherapy relies on the stimulation of the patient’s own immune system for an effective and lasting anti-tumor response, targeting and eliminating cancer cells. Both the research and clinical communities believe that combining cancer immunotherapy with more traditional anti-cancer treatments, such as radiation, is one of the more exciting new research areas in cancer treatment.

Charlie Garnett Benson, who is working on tumor immunity at Georgia State University, recently wrote about cancer immunity and combination therapy, the cutting-edge research areas listed in the new National Cancer Moonshot initiative highlighted by President Barack Obama in his final State of the Union address.

“Current cancer therapies include some combination of radiation, surgery, and chemotherapy for most patients. Ionizing radiation, one of the oldest and more commonly used types of cancer treatment, consists of high energy waves that damage the DNA of cancer cells leading to cell death, called cell suicide or apoptosis. But radiation can also affect the healthy cells surrounding tumor tissues, so there is a limit of how high a dose a patient can receive without leading to healthy cellular damage and death.”

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