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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I Thought Melanoma Would Kill Me. Here's Why It Didn't.

Excerpt:

“Several months ago, my wife, Françoise, and I attended something novel for melanoma patients: a survivors’ dinner. People said they wanted to make it an annual gathering. Planning anything that far in advance had been pointless for me. Two years ago, I was about to accept hospice care.

“When I was diagnosed in 1996, very early surgery was the only reliably successful treatment. A more advanced case was essentially a death sentence. Over the past five years, a series of revolutionary drugs have given me and many other people a surprisingly hopeful prospect. Nevertheless, the drugs’ development process has often been excruciating for participants in clinical trials, and the drugs’ remarkably high costs limit their value.”

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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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Ipilimumab plus T-VEC Shows Promise for Metastatic Melanoma

Excerpt:

“Talimogene laherparepvec plus ipilimumab demonstrated safety and efficacy among patients with untreated, unresectable advanced melanoma, according to study results published in Journal of Clinical Oncology.

“ ‘Tumor immunotherapy has become an established treatment of metastatic melanoma and is being increasingly applied to other cancer types,’ Igor Puzanov, MD, MSCI, associate professor of medicine at Vanderbilt University School of Medicine, and colleagues wrote. ‘A hallmark of tumors likely to respond to immunotherapy is a lymphocyte-predominant tumor microenvironment. To date, immunotherapy designed to promote lymphocyte accumulation within established tumors, activate lymphocyte function and cytotoxicity, and prevent T-cell suppression has shown the most promise.’ ”

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Considerations for Single-Agent Versus Combo Melanoma Immunotherapy

Excerpt:

“The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) continues to show promise, with recent data demonstrating a 26% improvement in overall survival (OS) with the 2 drugs compared with ipilimumab alone for patients with advanced melanoma.

“In a 2-year assessment of the phase II CheckMate-069 trial, which was recently presented at the 2016 AACR Annual Meeting, 142 treatment-naïve patients with unresectable stage III or metastatic stage IV melanoma were randomized to receive either the combination (n = 95) or ipilimumab plus placebo (n = 47) every 3 weeks for 4 doses followed by nivolumab or placebo every 2 weeks until disease progression or unacceptable toxicity.

“In the overall treatment population, the 2-year OS rate was 64% with the combination compared with 54% for ipilimumab alone (HR, 0.74; 95% CI, 0.43-1.26). The median OS at 2 years in patients randomized to either the combination or monotherapy has not been reached.”

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Can Patients Discontinue Immunotherapy and Still Benefit?

Excerpt:

“At present in clinical practice, immunotherapy with anti-PD-1 agents is administered indefinitely until intolerable toxicities or progressive disease sets in. But there has been anecdotal evidence that patients who stop treatment may still derive benefit, and now there is evidence of this from a post hoc analysis of a randomized study.

“It comes from the CheckMate 069 trial that evaluated the combination of nivolumab (Opdivo, Bristol-Myers Squibb Company) and ipilimumab (Yervoy, Bristol-Myers Squibb Company) vs ipilimumab alone in patients with metastatic melanoma.

“New results from a post hoc analysis of this trial, presented at the recent American Society of Clinical Oncology (ASCO) 2016 Annual Meeting (abstract 9518), show that a subgroup of patients who discontinued combination immunotherapy because of treatment-related adverse events achieved an impressive overall response rate (ORR) of 66%.”

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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…