I-SPY 2: Veliparib–Carboplatin Improves Complete Response Rate in Triple-Negative Breast Cancer

Excerpt:

“The addition of veliparib–carboplatin to standard chemotherapy appeared likely to improve rate of pathologic complete response among women with triple-negative breast cancer, according to results of I-SPY 2 published inThe New England Journal of Medicine.

“Researchers calculated an 88% predictive probability that the veliparib (ABT-888, AbbVie) and carboplatin combination would remain effective when added to standard chemotherapy in phase 3 confirmatory trials.”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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Combination of Nivolumab and Ipilimumab Moves Forward in NSCLC

Excerpt:

“How best to combine new immunotherapies is a burning question in oncology. A new study in the CheckMate series suggests that nivolumab (Opdivo) and ipilimumab (Yervoy) can be safely and effectively combined as first-line treatment of advanced non–small cell lung cancer (NSCLC), but further study is needed. This combination is being studied in the phase III CheckMate 227 trial. For now, a platinum-containing doublet is still the standard of care.

“ ‘Nivolumab plus ipilimumab has promising efficacy in advanced NSCLC. The combination is well tolerated, with no treatment-related deaths. Overall response rates range from 39% to 47%, and median duration of response has not yet been reached,’ said lead author Matthew Hellmann, MD, of Memorial Sloan Kettering Cancer Center, New York.

“Both nivolumab and ipilimumab enhance T-cell antitumor activity. The combination of nivolumab plus ipilimumab has been approved for the treatment of melanoma by the U.S. Food and Drug Administration (FDA). Nivolumab monotherapy has been approved by the FDA for adults with locally advanced NSCLC progressing after platinum-doublet chemotherapy.”

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Beyond PD-1/CTLA-4: Immunotherapy Combos Explore New Ground

Excerpt:

“A variety of dual immunotherapy combination regimens are currently under exploration that could build upon the success seen with the addition of the CTLA-4 inhibitor ipilimumab (Yervoy) to PD-1 blockade with nivolumab (Opdi­vo) for the treatment of patients with advanced melanoma, explained Omid Hamid, MD.

” ‘On the heels of the ipilimumab/nivolumab combination having such a high response rate, 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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Incyte Announces First Patient Treated in ECHO-301 Phase 3 Study

Excerpt:

“Incyte Corporation (INCY) today announced that the first patient has been treated in the ECHO-301 study—a Phase 3 trial evaluating epacadostat, Incyte’s investigational, highly potent and selective oral IDO1 inhibitor, in combination with Keytruda®(pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma. Incyte expects initial data from the ECHO-301 study to be available in 2018…

“ ‘We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase 3 program evaluating epacadostat in combination with pembrolizumab,’ said Steven Stein, M.D. Incyte’s Chief Medical Officer. ‘This trial—the first to test this combination in a pivotal study—is part of the larger ECHO program evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumor types.’ “

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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


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

Excerpt:

“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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