MPIP: Melanoma Patients Information Page

The MPIP is the oldest and largest community of people affected by melanoma hosted through the Melanoma Research Foundation. It is designed to provide support and information to caregivers, patients, family and friends. Once you have been touched by melanoma—either as a patient or as a family member or friend of a patient—you become part of a community. It is not a community anyone joins willingly. But if you must be part of this group, you will find no better place to find the tools you need in your journey with this cancer, and the friends who can make that journey more bearable.

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Replies by: Janner, JulietJ, DonW, LibbyinVA, JerryfromFauq, Anonymous

Hi all,

This is my first time posting here. I've read many of the posts and appreciate all the good information and wisdom.

I'm posting on behalf of my Dad. He had a melanoma excised from his face in May by a plastic surgeon after his dermatologist took a biopsy and it came back positive. I did not see a pathology report, but the doctor told him it was in situ.

He got a call today that his lab work came back without clear margins, and they called him in for an appointment. He came home with another bandage on the OTHER side of his face - they had seen another suspicious mole and done a biopsy. And they've scheduled him for another excision in early July to get the rest of the cells that they didn't get the first time around. If the new biopsy turns out to be anything, they'll take care of that one in July too.

He's worried about the news, and I try to reassure him that they just didn't have a proper reading the first time - it's an inexact science, right? - and that they just missed some cells. But I'm worried that it's a recurrence at the same site - can that happen so soon after the original treatment? (Just a month.) Or are we safe assuming that they just didn't get it all the first time?

Thank you all for any insight you might have. I wish you all the best with your and your loved ones' treatment.

Julie

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Research June 06, 2013

 

 

Score One for Nivolumab/Ipilimumab Combo in Advanced Melanoma

N. Engl. J. Med. 2013 Jun 02;[EPub Ahead of Print], JD Wolchok, H Kluger, MK Callahan, MA Postow, NA Rizvi, AM Lesokhin, NH Segal, CE Ariyan, R-A Gordon, K Reed, MM Burke, A Caldwell, SA Kronenberg, BU Agunwamba, X Zhang, I Lowy, HD Inzunza, WFeely, CE Horak, Q Hong, AJ Korman, JM Wigginton, A Gupta, M Sznol

 

 

TAKE-HOME MESSAGE

Researchers combined nivolumab plus ipilimumab in patients with advanced melanoma. Results demonstrated remarkable response rates, along with a manageable safety profile.

Commentary by

Immunotherapeutic approaches to cancer continue to excite oncologists, and with good reason. A presentation by Jedd Wolchok of Memorial Sloan-Kettering Cancer Center presented at the ASCO 2013 meeting, and published simultaneously in The New England Journal of Medicine, focused on the combination of ipilimumab, an FDA-approved CTLA-4 antagonist, and nivolumab, an investigational PD-1 inhibitor, for the treatment of patients with advanced melanoma. Both drugs affect the immune system by reducing the so-called "brake mechanism" by interfering with T-cell inhibitory checkpoints, which normally prevent innate immunosurveillance of cancer cells. By targeting two different points along this pathway, preclinical studies had demonstrated additive benefits over one drug alone.

In this phase I study, the results were dramatic: a 40% response rate, clinical activity in 60% of patients, many complete/near complete responses, and very long duration of response. The concurrent administration of these agents appeared to be superior to a sequential approach, and the maximal tolerated dose of the combination was established.  Given the fact that other PD-1 antibodies have also shown impressive activity, as seen with lambrolizumab in an article published in the same issue of NEJM, and the promising results of this approach in common cancers such as non–small cell lung cancer, we appear to be entering an era when the ultimate personalized therapy—a patient's own uniquely specific immune system—provides tangible, long-lasting benefit against cancer.

SUMMARY

PracticeUpdate Editorial Team

Background: In patients with melanoma, ipilimumab (an antibody against cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4]) prolongs overall survival, and nivolumab (an antibody against the programmed death 1 [PD-1] receptor) produced durable tumor regression in a phase 1 trial. On the basis of their distinct immunologic mechanisms of action and supportive preclinical data, we conducted a phase 1 trial of nivolumab combined with ipilimumab in patients with advanced melanoma.

Methods: We administered intravenous doses of nivolumab and ipilimumab in patients every 3 weeks for 4 doses, followed by nivolumab alone every 3 weeks for 4 doses (concurrent regimen). The combined treatment was subsequently administered every 12 weeks for up to 8 doses. In a sequenced regimen, patients previously treated with ipilimumab received nivolumab every 2 weeks for up to 48 doses.

Results: A total of 53 patients received concurrent therapy with nivolumab and ipilimumab, and 33 received sequenced treatment. The objective-response rate (according to modified World Health Organization criteria) for all patients in the concurrent-regimen group was 40%. Evidence of clinical activity (conventional, unconfirmed, or immune-related response or stable disease for ≥24 weeks) was observed in 65% of patients. At the maximum doses that were associated with an acceptable level of adverse events (nivolumab at a dose of 1 mg per kilogram of body weight and ipilimumab at a dose of 3 mg per kilogram), 53% of patients had an objective response, all with tumor reduction of 80% or more. Grade 3 or 4 adverse events related to therapy occurred in 53% of patients in the concurrent-regimen group but were qualitatively similar to previous experience with monotherapy and were generally reversible. Among patients in the sequenced-regimen group, 18% had grade 3 or 4 adverse events related to therapy and the objective-response rate was 20%.

Conclusions: Concurrent therapy with nivolumab and ipilimumab had a manageable safety profile and provided clinical activity that appears to be distinct from that in published data on monotherapy, with rapid and deep tumor regression in a substantial proportion of patients.

The New England Journal of Medicine
Nivolumab Plus Ipilimumab in Advanced Melanoma
N. Engl. J. Med. 2013 Jun 02;[EPub Ahead of Print], JD Wolchok, H Kluger, MK Callahan, MA Postow, NA Rizvi, AM Lesokhin, NH Segal, CE Ariyan, R-A Gordon, K Reed, MM Burke, A Caldwell, SA Kronenberg, BU Agunwamba, X Zhang, I Lowy, HD Inzunza, WFeely, CE Horak, Q Hong, AJ Korman, JM Wigginton, A Gupta, M Sznol

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KT's picture
Replies 1
Last reply 6/7/2013 - 7:34pm
Replies by: LibbyinVA

Every time I see an anti-smoking commercial or pamphlet, I think, "why isn't there more of an anti-tanning campaign?" All day I see and hear commercials for tanning salons, boasting the "healthful" effects of vitamin D and student discounts. And, though melanoma awareness is higher than ever, it still seems like people still dispute whether tanning is really that bad for you. I've seen one good magazine campaign and one commercial, but it's not on anymore :( I know people will always tan, or smoke, but at least smokers undeniably know that it's a bad choice.

It makes me want to walk in there with my many scars and disfigurements exposed. I want to picket them with photos of when I had so many stitches I looked like Frankenstein, and when I was sick after months of treatment... I want them to see my beautiful young face behind an oxygen tube. I want them to see my medical bills.

Is it just me?

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Anonymous's picture
Anonymous
Replies 5
Last reply 6/11/2013 - 12:49pm

Hi - my father has stage 4 melanoma in his lungs.  He was on ippi at Sloan Kettering and after series of treatment the drs decided to put him on PD-1 at Yale (my parents live closer to Yale).  Fortunately he hasn't had any reactions/symptons to both drugs and over the course of the past year (when he started PD-1), 80% of the lesions went away.  Unfortunately we found out about a week ago that 2 lung lesions were seen as progressing and one was found in the rib and one in the breathing tube. So now he is going back on ippi.  Has anyone been through something similar?  It seems as though if ippi doesn't work, the next step would be to go to Nat'l Institute of Health.  Any thoughts/experiences would be very much appreciated! 

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Anonymous's picture
Anonymous
Replies 0

Hi - my father has stage 4 melanoma in his lungs.  He was on ippi at Sloan Kettering and after series of treatment the drs decided to put him on PD-1 at Yale (my parents live closer to Yale).  Fortunately he hasn't had any reactions/symptons to both drugs and over the course of the past year (when he started PD-1), 80% of the lesions went away.  Unfortunately we found out about a week ago that 2 lung lesions were seen as progressing and one was found in the rib and one in the breathing tube. So now he is going back on ippi.  Has anyone been through something similar?  It seems as though if ippi doesn't work, the next step would be to go to Nat'l Institute of Health.  Any thoughts/experiences would be very much appreciated! 

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JC's picture
Replies 1
Last reply 6/7/2013 - 9:11am
Replies by: Janner

called it "precancer". . going to do cryosurgery to treat, is that the standard treatment?

 

thanks

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Replies by: fairlinda, kylez, AllyNTAus, DeniseK, Anonymous

Bill was only diagnosed on 4-1-13.  Maybe 5 brain tumors, one lymph gland, lungs.  Did WBR to no avail.  Started Yervoy.  Because of a fall at home, another CT done on 5/2 and not only were there new tumors but the first ones had grown.  Doc said he wouldnt live to benefit from Yervoy so we switched to the faster acting Zelboraf.  Just finished our first month and nothing is better.  The new tumor(s) caused his left side to not cooperate at all. He still has strength, it just can't get a signal.  Now his right side is showing signs of weakness.  I am still trying to maintain him at home but transfers have become challenging at best.  Anyone have improvement after a month while matters seemed to be worsening?  I'm so looking for hope.

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Bill was only diagnosed on 4-1-13.  Maybe 5 brain tumors, one lymph gland, lungs.  Did WBR to no avail.  Started Yervoy.  Because of a fall at home, another CT done on 5/2 and not only were there new tumors but the first ones had grown.  Doc said he wouldnt live to benefit from Yervoy so we switched to the faster acting Zelboraf.  Just finished our first month and nothing is better.  The new tumor(s) caused his left side to not cooperate at all. He still has strength, it just can't get a signal.  Now his right side is showing signs of weakness.  I am still trying to maintain him at home but transfers have become challenging at best.  Anyone have improvement after a month while matters seemed to be worsening?  I'm so looking for hope.

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Not about melanoma specifically, but probably still applicable.

 

http://www.nature.com/nm/journal/v19/n6/full/nm.3244.html?WT.ec_id=NM-20...

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LibbyinVA's picture
Replies 6
Last reply 6/7/2013 - 7:06pm

In the interest of giving some hope to others, just want to let everyone know that today I am celebrating my 8th year of being NED. I won't bore you with all the details as you can check my profile if you want more information. Melanoma certainly left its mark on me but I am still winning. Believe in miracles...I am one!

LibbyinVA-Stage IIIb

I have melanoma but melanoma does not have me!

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ecc26's picture
Replies 12
Last reply 6/8/2013 - 10:01am
Replies by: ecc26, jP85, DeniseK, Anonymous, DonnaK, POW

Hello,

I posted a little while ago looking for others who might have had new tumors show up after an apparent response to IL2 and also asking about the bruising/inflamation that was happening with these new tumors. Thank you to those of you who responded. I do appreciate it. 

At the time of the last posting I had had a CT which ended up showing that all of the new tumors were subQ, which is the best possible scenario. On Monday I also had an MRI in preparation for an appointment at Dana-Farber (yesterday) to investigate whether I should persue clinical trials (specifically for the PD1 drugs or a PD1/Ipi combo trial as I am Ipi naive) or try Ipi first. When I picked up the imaging discs from the MRI, CT and the PET from before my last round of IL2 I read the MRI report and found that I have 7 brain mets with "several" in the leptomeninges (network of blood vessels, etc surrounding the brain) as well. These results disqualify me from the clinical trials and are too numerous for either surgery or gamma knife. It changed the conversation at Dana-Farber from "what trials are there and should I persue them?" to "is there anything I can do?".

The advice was to pursue whole brain radiation concurrently with Ipi (to try and take advantage of the abscopal effect) in hopes of at least reducing/stabilizing the tumors to hopefully make me eligible for trials in a few months. I have an appointment with my local oncologist tomorrow where things will likely be set in motion. He gave me a paper (haven't read it yet) showing that Ipi works just as well in those with brain mets as in those without them, though it still has the same low response rate. We had a discussion about the abscopal effect and the possibility that it increases the chances of getting a response from Ipi (he gave me a paper on that too). None of this makes me any less concerned about the fact that my brain filling with tumors, or makes me feel any better about what they indicate prognostically. 

I'm also trying to track down my BRAF results (or if it was ever done, as I was told it was). 

Has anyone else done both radiation and ipi at the same time? If so, what were your side effects? I have avoided researching radiation so far in my process hoping I would never have to so I don't know as much about it- how long is a course for whole brain radiation? How long do the side effects (nausea, etc) last after your last dose? Do they dissipate quickly or hang around for a long time?

Any input is appreciated,

Eva

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flvermonter's picture
Replies 3
Last reply 6/6/2013 - 8:15pm

hi again
sitting at Moffitt while my husband is in surgery with Dr Zager. I know I will meet with him after, but wondered what options for treatment next. they are removing the rest of the nodes on the right side. I read that chemo is not usually an option and also not normally radiation. I know we will have to wait for the pathology report. what would be the options for his treatment next. thanks mary

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NYKaren's picture
Replies 4
Last reply 6/7/2013 - 3:25pm
Replies by: NYKaren, jag, POW, kylez

So Dr. Wolchok just called to tell me the Merck Phase 1 PD1 trial I was aiming for has been closed by Merck--or at least they've closed seats at sloan. He said it was Merck's edict with no exceptions. Boy am I upset.
He said my 2 choices are to go back on Zel or see Dr. Pavlick at NYU where they have seats in the phase 2 trial w/the chemo arm.
I choose to at least see Dr P next week and see what she thinks. I know she's good, it's not a matter of that, it's whether I want to possibly go through the effects of chemo. But I'm afraid if I go back on Zel, the Mel will just come back soon, when there might not be a trial seat available.

Any ideas, thoughts, suggestions??
:(
Karen

Don't Stop Believing

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News June 02, 2013
 

Adding GM CSF to Ipilimumab Extends Survival in Metastatic Melanoma

 

IMNG Medical Media,  2013 Jun 02 , MJ Dales

Dr. F. Stephen Hodi, Jr.

CHICAGO (IMNG) – Combining two approved therapies – GM CSF and ipilimumab – extended overall survival rates by 35% and resulted in fewer grade 3-5 adverse events when compared with ipilimumab alone in a randomized study of 245 patients with metastatic melanoma.

At 1 year, the overall survival rate in the combination therapy group was 69%, with a median follow-up of nearly 18 months. At 1 year, survival in the ipilimumab-only group was 53% with a median follow-up of nearly 13 months, Dr. F. Stephen Hodi, Jr. reported at the annual meeting of the American Society of Clinical Oncology.

This is the first phase II trial to look at ipilimumab (Yervoy, Bristol-Myers Squibb) and the granulocyte macrophage colony-stimulating factor (GM CSF) sargramostim (Leukine, Sanofi) in combination in any cancer, said Dr. Hodi, the principal investigator for the trial, which was conducted by the ECOG-ACRIN Cancer Research Group (formerly the Eastern Cooperative Oncology Group) trial. In this study, ipilimumab was used at a dose of 10 mg/kg, which is higher than the FDA-approved dose of 3 mg/kg.

“We are waiting for the data to mature in ongoing studies examining the relative efficacy of 3 mg/kg and 10 mg/kg dosing,” said Dr. Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston.

The results in the current trial are another indication of the impact that immunotherapy can have for patients with advanced melanoma. Since both GM CSF and ipilimumab are commercially available, oncologists need to determine the best way to apply these findings in everyday practice. The next step will then be to define the role of GM CSF in combination with other immune checkpoint targeting drugs, such as therapies that target the PD-1 and PD-L1 pathway, he said.

“We have been using GM CSF in melanoma as a stand-alone therapy,” Dr. Lynn M. Schuchter, the C. Willard Robinson Professor of Hematology-Oncology at the University of Pennsylvania, Philadelphia, and an expert on melanoma, said at a press conference where the study results were announced. “It will be interesting to see if payers will cover this (combination treatment).”

Ipilimumab targets CTLA-4, a protein that keeps immune T-cells in an inactive state. GM CSF is a growth factor commonly used to boost white blood cell counts after chemotherapy or stem cell transplantation.

For this study, 245 patients were randomized to receive ipilimumab plus GM CSF or ipilimumab alone. All study participants were in otherwise good health, with an ECOG performance status of 0-1 and adequate end-organ function, no autoimmune disease, and no prior use of CTLA-4 blockade or CD137 agonists. All had radiographically measurable metastatic melanoma, but with no CNS metastases, and had received up to one prior treatment over 4 weeks before starting in the trial.

The 123 patients randomized to the combination therapy were given sargramostim at 250 micrograms injected subcutaneously on day 1-14 of a 21 day cycle. For induction therapy, ipilimumab was given at a dose of 10 mg/kg intravenously once every 3 weeks for four cycles as induction therapy and once every 12 weeks as maintenance therapy. The 122 patients randomized to ipilimumab alone received the drug on the same schedule.

In both study arms, tumor shrinkage rates were comparable at 11% and 14%, and progression-free survival was similar at about 3 months. But the overall survival rate was longer in the combination treatment arm. One year after the start of therapy and with a median follow-up of 13.3 months, 69% of patients given the combination therapy and 53% of those who got ipilimumab alone were still alive, for a 35% lower risk of death with the combination therapy (hazard ratio, 0.64; P = .014).

Additionally, the combination treatment was associated with fewer serious side effects, compared with ipilimumab alone. The most significant differences were in lung and gastrointestinal toxicities.

Grade 3-5 adverse events occurred in 45% of patients given the combination therapy and in 57% given ipilimumab alone (p2 = 0.078). There were two possible treatment-related deaths in the combination arm (one colonic perforation and one cardiac arrest) and 7 possible treatment-related deaths in the ipilimumab-only arm: (two cases of multi-organ failure, two colonic perforations, one case of liver failure, and two cases of respiratory failure).

The research was supported in part by the National Cancer Institute (Cancer Therapy Evaluation Program), Sanofi, and Bristol-Myers Squibb. Dr. Hodi disclosed receiving research funding and a being a consultant or in an advisory role with Bristol-Myers Squibb.

 

 

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News June 03, 2013
 

Selumetinib is First Therapy to Shrink Uveal Melanomas

 

IMNG Medical Media,  2013 Jun 03 , MJM Dales

Dr. Richard D. Carvajal

CHICAGO (IMNG) – Selumetinib, an investigational MEK 1/2 inhibitor, shrank uveal melanomas in half of all treated patients, with a duration of disease control that was more than twice that achieved with the comparator therapy temozolomide, based on the final analysis of data from 98 patients in a phase II crossover study.

This is the first clinical trial to identify a drug that improves clinical outcome in patients with advanced melanoma of the eye, said Dr. Richard D. Carvajal, who presented the data at the annual meeting of the American Society of Clinical Oncology.

“Selumetinib is a new standard of therapy for uveal metastatic melanoma,” he said at a press conference announcing the results. Before this study, there was no evidence that any systemic therapy was truly effective in this disease. In eight different clinical trials conducted in the last decade, 2 of 157 patients have responded to potential new therapies, including chemotherapy, targeted therapy, and immunotherapy.

With about 2,000 cases diagnosed each year in the United States, uveal melanoma is an orphan disease that is biologically distinct from cutaneous melanoma. Treatment consists of surgery to remove the tumor or eye, as well as radiation therapy or chemotherapy. About half of cases metastasize, and survival for these patients is 9-12 months.

In this study, 98 patients with metastatic melanoma of the eye were randomly assigned to receive selumetinib or temozolomide (Temodar), with 48 receiving selumetinib and 50 receiving temozolomide. Based on imaging studies using RECIST (Response Evaluation Criteria in Solid Tumors), patients whose disease worsened on temozolomide were permitted to cross over to selumetinib.

Looking at the response patterns, tumors regressed in 11% (RECIST response, 0%) of 46 evaluable patients in the temozolomide arm and in 50% (RECIST response, 15%) of 46 evaluable patients in the selumetinib arm, for a highly significant hazard ratio of 0.46, reported Dr. Carvajal of Memorial Sloan-Kettering Cancer Center in New York.

Progression-free survival was improved to nearly 16 weeks for selumetinib as compared with 7 weeks for temozolomide. Overall survival was 10.8 months for selumetinib and 9.4 months with temozolomide.

More than 90% of patients in both arms of the study had metastatic liver disease and more than 50% had an elevated lactate dehydrogenase, Dr. Carvajal noted. Further, the study allowed for crossover to selumetinib by temozolomide-treated patients with no evidence of response at 4 weeks; 80% of patients in the temozolomide arm crossed over to selumetinib.

Selumetinib blocks the MEK protein, a key component of the MAPK pathway, which is activated by Gnaq and Gna11 gene mutations, found in 84% of the uveal melanoma patients in the study. Selumetinib also is being investigated for the treatment of cancers of the thyroid and lung, and trials are underway with selumetinib in combination with other drugs.

Dr. Carvajal noted that another MEK inhibitor, trametinib (Mekinist, GlaxoSmithKline), recently became the first MEK inhibitor to be approved by the Food and Drug Administration. Trametinib was approved in May 2013 as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations.

AstraZeneca is developing selumetinib under a licensing agreement with Array Biopharma.

The selumetinib study was supported in part by a Conquer Cancer Foundation of ASCO Career Development Award, the National Institutes of Health, Cycle for Survival, and the Fund for Ophthalmic Knowledge. Dr. Carvajal had no relevant financial disclosures.

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News June 02, 2013

Nivolumab Activity is Durable in Advanced Melanoma

IMNG Medical Media,  2013 Jun 02 , MJ Dales

Dr. Mario Sznol

CHICAGO – Nivolumab, an investigational PD-1 inhibitor, shrank tumors by at least 30% in 33 of 107 pretreated patients with metastatic melanoma, based on results from an expanded phase I trial reported at the annual meeting of the American Society of Clinical Oncology.

An additional 11% of patients had prolonged stable disease or non-conventional, immune-related response profiles.

The findings build on favorable initial results reported at last year’s annual meeting for nivolumab in melanoma, renal cell carcinoma, and nonsmall cell lung cancer. The latest results in melanoma patients at follow-ups as long as 2 years indicate no new safety signals with nivolumab, which was associated with a 21% rate of grade 3-4 events. The rate of severe immune-related adverse events was 5%, and there were no cases of grade 3 or higher pneumonitis.

Median overall survival was nearly 17 months with nivolumab, with a 2-year survival rate of 43%. Median overall survival with vemurafenib (Zelboraf) is 16 months and with ipilimumab (Yervoy) is 10 months, with 2-year survival rates of 24% to 33% with ipilimumab, according to Dr. Mario Sznol, who presented the results from the phase I trial.

“We’re very excited that there is potential for even more activity [with nivolumab] in combination with other drugs,” said Dr. Sznol, professor of medicine (medical oncology) at the Yale Cancer Center in New Haven, Conn.

Responses were seen at all five dose levels tested (0.1, 0.3, 1, 3, and 10 mg/kg), with a 41% objective response rate at the 3 mg/kg dose, which has been selected for evaluation in phase III studies.

Median overall survival across all doses of nivolumab was 16.8 months. It reached 20.3 months for the 3 mg/kg dose. The 1-year survival rate was 62% and the 2-year survival rate, 43%.

Patients in the nivolumab trial were representative of typical patients with advanced melanoma, Dr. Sznol said. All patients in the study had disease that worsened despite prior standard systemic therapies, 25% of them had three or more prior therapies and 63% had two or more prior therapies.

All had ECOG performance standards of 0 or 1. Patients received up to 12 cycles of treatment, with four doses of nivolumab per cycle, until discontinuation criteria were met.

Response has persisted after stopping treatment in 17 of 33 patients, with 12 of the 17 continuing to respond for at least 4 months, Dr. Sznol said.

The overall objective response rate included partial and complete responses. Dr. Sznol acknowledged that just one patient had a verified complete response to nivolumab and four others had near complete responses at 2 years. Historical response rates to immunotherapy drugs are 5%-10% in advanced melanoma, he noted, which is lower than the 30% response seen in these pretreated patients.

“I have seen a few relapses after 2 years of response, but some patients continue to do well at 4 years. One patient who has been off nivolumab for 2 years continues to do well at over 4 years,” Dr. Sznol commented during a question and answer session.

To define the best candidates for nivolumab, molecular markers need to be identified to predict probable response, he added. As nivolumab is a PD-1 inhibitor, one potential marker is the protein PD-L1 on the surface of tumor cells, which is being studied in several other clinical trials.

The research was supported by Bristol-Myers Squibb. Dr. Sznol disclosed that he serves in a consultant or advisory role with Bristol-Myers Squibb.

 

 

 

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