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Trial Heralding a ‘New Day’ for Melanoma Meets with Guarded Enthusiasm

Trial Heralding a ‘New Day’ for Melanoma Meets with Guarded Enthusiasm

ABSTRACT: Ipilimumab has being lauded as a monumental advance in the field of immuno-oncology. While the news is certainly promising, unanswered questions remain and the melanoma community must proceed with caution.
A PET/CT fusion image
Photomicrograph of metastatic malignant melanoma in the human lymph node, section, H&E stain, magnified 10× at 24 × 36 mm.
©Carolina Biological Supply Company/PhototakeUSA.com

For a disease that is most closely linked to the sun, melanoma has seen some very dark days—the last approval for a treatment regimen, interleukin-2, took place nearly 12 years ago. Since then, multiple trials have been conducted with new agents or combination therapies and the results have been mostly dismal (J Clin Oncol 26:527-534, 2008).

When a new trial offered more than a ray of hope in melanoma therapy, it was no surprise that the spotlight shone with full force: The phase III MDX010-20 trial, which tested ipilimumab (see Fact box on page 20) and a gp100 peptide vaccine in metastatic melanoma, landed a coveted spot in an ASCO 2010 plenary session, with the results published simultaneously in the New England Journal of Medicine online (June 5, 2010; updated on June 14, 2010).


"I feel that I'm presenting [these data] not only for my co-investigators but also for the clinicians who have worked in this disease over the many decades as we've faced great disappointment. But finally we are getting good news," said lead investigator Steven O'Day, MD, during his plenary session address (abstract 4).

The excitement generated by the results extended beyond the ASCO meeting, with mass media spreading the word like sunshine: A "cure" for melanoma had been discovered.

"I've already gotten dozens of requests for this drug," said Sanjiv Agarwala, MD, chief of hematology and oncology at St. Luke's Hospital and Health Network in Bethlehem, Penn. "We are going to have a compassionate use program here soon [for this drug] and there's already a waiting list. But what's interesting is that when people talk to me about this, they say 'There's been a new drug approved for melanoma' or 'There's a cure for melanoma,' and I have to point out that nothing has been approved yet and that it's not a cure" (see Vantage Point).

While there's no doubt that the MDX010-20 trial is a major breakthrough, is it a breakthrough of epic proportions? Oncology News International spoke with experts who concurred that the results are quite meaningful—but only to a point.

"Before we say 'Aha, we've got it,' we have to look at the limitations of this study. . .while an important advance, it opens up more questions than it resolves," said Lee Cranmer, MD, PhD, an assistant professor of clinical medicine at the University of Arizona in Tucson.


'A base hit but not a home run'

Results from the MDX010-20 trial are certainly a step in the right direction, Dr. Agarwala said. "It's a base hit but not a home run. This drug benefits a subset of patients, about 10% of melanoma patients overall I would say, and, again, it's a good step."

The results will change the landscape for future melanoma trials as other drugs will have to be compared to ipilimumab, added Dr. Agarwala, principal investigator for a phase II trial of PV-10 in metastatic melanoma (see Related Reading, at left).

Dr. Agarwala also participated in and was principal investigator for the phase III PRISM trial, which evaluated sorafenib (Nexavar) with carboplatin and paclitaxel as second-line treatment in advanced melanoma patients (J Clin Oncol 27:2823-2830, 2009).

There's still plenty of work that needs to be done in terms of combining ipilimumab with other agents, sequencing, and dosing, he said. "With these ipilimumab results, we now have another treatment option for our patients, but that that doesn't mean that every person with melanoma who walks through the door is going to get this drug and will be cured."


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