Melanoma: New Drugs and New Challenges (Part 1 of 2)


New targeted and immunotherapy drugs have changed the diagnosis of metastatic melanoma from a death sentence into a disease that can potentially be managed and even cured. Nevertheless, these new drugs do not work in all patients, or they may stop working after a transient response. This post (part one of two) will describe ongoing efforts to find drug combinations with higher efficacy than single drugs and decipher the mechanisms underlying drug resistance. Continue reading…


Novel Combination Study Planned for SCLC

Excerpt:

“A phase I/II study will explore the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer (SCLC).

“AbbVie, the developer of rovalpituzumab tesirine, and Bristol-Myers Squibb, the company marketing nivolumab and ipilimumab announced the phase I/II study in a joint press release. As single-agents, rovalpituzumab tesirine and nivolumab have each demonstrated promising early findings for patients with SCLC. Additionally, nivolumab plus ipilimumab sparked promising response rates and overall survival (OS) findings. Data for the 3 agents were recently presented at the 2016 ASCO Annual Meeting.”

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Immunotherapy/Chemo Combinations Show Potential in NSCLC

Excerpt:

“Pembrolizumab (Keytruda) and nivolumab (Opdivo) have both made a significant difference for a high number of patients with advanced non–small cell lung cancer (NSCLC). However, there is still a great deal to learn about the optimal use of PD-1 inhibitors in the disease, says Shirish Gadgeel, MD.

“ ‘Both pembrolizumab and nivolumab are approved for the management of NSCLC and have shown activity,’ says Gadgeel, medical oncologist, leader of the Thoracic Oncology Multidisciplinary Team at Karmanos Cancer Center, Wayne State University. ‘When these agents do work, the benefit is for a prolonged period of time. However, these agents are only efficacious in a minority of patients—probably in the range of 20%.’ ”

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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.

Continue reading…


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…