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Oncology Advances October 2014

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Dana-Farber/Brigham and Women's Cancer Center | 3 Hormone Receptor Positive Breast Cancer: Testing New Adjuvant Combinations Erica L. Mayer, MD MPH, a medical oncologist in the Susan F. Smith Center for Women's Cancers, detailed an ongoing pilot single-arm Phase II study evaluating the feasibility of combining palbociclib, a novel CDK4/6 inhibitor, with adju- vant endocrine therapy for patients with Stage II and Stage III hormone receptor positive breast cancer. Palbociclib has previously shown encouraging results in a randomized Phase II trial in metastatic hormone receptor positive breast cancer in which the combination of palbociclib with the endocrine agent letrozole in the first line setting almost doubled pro- gression-free survival compared with letrozole alone. The pilot study aims to enroll 160 patients with a history of Stage II or Stage III hormone receptor positive breast cancer who have already demonstrated tolerance of adjuvant endocrine therapy. Palbociclib will be added to the regimen for a goal duration of two years. The primary endpoint of the study will be to determine the feasibility of completion of the planned two years of therapy in this adjuvant population. Advanced Non-small Cell Lung Cancer: New Targeted Therapy Overcomes Resistance to EGFR Inhibitors Pasi A. Jänne, MD, PhD, Director of the Lowe Center for Thoracic Oncology, reported results from a current Phase I dose-escalation study that is evaluating AZD9291, a drug that is effective against the EGFR T790M mutation, in patients previously treated with existing EGFR inhibitors, including erlotinib and gefitinib. Among the 199 patients en- rolled in the study as of January 16, 2014, 51 percent have responded to AZD9291. In patients with the T790M mutation, 67 percent responded to the therapy. As a result of these initial results, the U.S. Food and Drug Administration (FDA) has given breakthrough therapy designation to AZD9291 in order to expedite the review of this promising drug. (See page 4 for more information.) Metastatic Melanoma: Immunotherapy Demonstrates Durable Efficacy F. Stephen Hodi, MD, Director of the Center for Melanoma Oncology and Center for Immuno-Oncology, presented the longest follow-up of patients treated with a PD-1 inhibitor. In a trial of 107 patients with refractory metastatic melanoma who received nivolumab between 2008 and 2012, the fol- low-up showed a one-year survival rate of 63 percent, two- year survival rate of 48 percent, and three-year survival rate of 41 percent. Thirty-two percent of patients in the study had objective responses to nivolumab, and the median du- ration of the response was 22.9 months. Nivolumab is part of a new class of drugs that target PD-1, and ongoing trials of this therapy are available. (See page 6 and 7 for descrip- tions of select active trials.) F. Stephen Hodi, MD Director, Center for Melanoma Oncology; Director, Center for Immuno-Oncology, Dana-Farber/Brigham and Women's Cancer Center Erica L. Mayer, MD, MPH Medical Oncologist, Susan F. Smith Center for Women's Cancers, Dana-Farber/Brigham and Women's Cancer Center Pasi A. Jänne, MD, PhD Director, Lowe Center for Thoracic Oncology, Dana-Farber/Brigham and Women's Cancer Center Partial response of metastatic melanoma to nivolumab, with continued tumor regression after drug discontinuation. This 59-year-old woman previously had experienced disease progression following high-dose interleukin-2, temozolomide, and sorafenib therapies. She received nivolumab 10 mg/kg every two weeks and achieved a partial tumor regression at two months. Treatment was discontinued at eight months (four treatment cycles) as a result of exacerbation of an upper extremity neuropathy. Tumor regression continued after drug discontinuation. Computed tomographic scanning was performed with oral contrast but without intravenous contrast dye. Gold arrows indicate melanoma metastases involving (A) the right adrenal gland, (B) small bowel, and (C) mesenteric lymph nodes. J Clin Oncol. 2014 Apr 1;32(10):1020-30. Reprinted with permission from American Society of Clinical Oncology. Leaders in Cancer Treatment and Research

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