› Forums › General Melanoma Community › MK-3475 -Pneumonitis
- This topic has 12 replies, 4 voices, and was last updated 9 years, 1 month ago by eric w.
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- March 15, 2015 at 3:41 pm
Hi all,
My wife has had #14 doses of Mk-3475 and developed pneumontis. She just finished a two week course of prednisone and will get repeat CT of the chest area in a few weeks. Curious other folks experiences with pd-1 and pneumontis and associated responses. Thanks
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- March 16, 2015 at 9:05 pm
Hi Eric, I am in a study with BMS and it's Pd-1 drug (Nivolumab), 14 months into the trial. They gave me a package when I started with all the possible side effects. I don't know how close the % are with the Merck drug that your wife got but in my case the chance of getting pneumonitis runs between 5 to 20 % of patients. This data would have been based on phase One trials. I have been lucky so far and only had mild side effects that are listed on the possible side effects. If you go to the Merck web site I am sure they would provide you with their data. Wishing you the best. Ed
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- March 16, 2015 at 9:05 pm
Hi Eric, I am in a study with BMS and it's Pd-1 drug (Nivolumab), 14 months into the trial. They gave me a package when I started with all the possible side effects. I don't know how close the % are with the Merck drug that your wife got but in my case the chance of getting pneumonitis runs between 5 to 20 % of patients. This data would have been based on phase One trials. I have been lucky so far and only had mild side effects that are listed on the possible side effects. If you go to the Merck web site I am sure they would provide you with their data. Wishing you the best. Ed
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- March 16, 2015 at 9:05 pm
Hi Eric, I am in a study with BMS and it's Pd-1 drug (Nivolumab), 14 months into the trial. They gave me a package when I started with all the possible side effects. I don't know how close the % are with the Merck drug that your wife got but in my case the chance of getting pneumonitis runs between 5 to 20 % of patients. This data would have been based on phase One trials. I have been lucky so far and only had mild side effects that are listed on the possible side effects. If you go to the Merck web site I am sure they would provide you with their data. Wishing you the best. Ed
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- March 16, 2015 at 9:32 pm
Pneumonitus is quite common with immunotherapies. I'm not sure of the percent but it is best to catch it early so I hope that is what happened and your wife is fine now. Also it is my understanding when the pd1s were in trial the patients once cleared were able to continue with the pd1 fine. I just had dose 15 of keytruda (Ie mk-3475) last week and have not experienced that side affect yet. Actually not much affects at all even the fevers I used to get I haven't in about 7 weeks which was part way through another batch of radiations. So I hope it is still working.
Artie
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- March 16, 2015 at 9:32 pm
Pneumonitus is quite common with immunotherapies. I'm not sure of the percent but it is best to catch it early so I hope that is what happened and your wife is fine now. Also it is my understanding when the pd1s were in trial the patients once cleared were able to continue with the pd1 fine. I just had dose 15 of keytruda (Ie mk-3475) last week and have not experienced that side affect yet. Actually not much affects at all even the fevers I used to get I haven't in about 7 weeks which was part way through another batch of radiations. So I hope it is still working.
Artie
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- March 16, 2015 at 9:32 pm
Pneumonitus is quite common with immunotherapies. I'm not sure of the percent but it is best to catch it early so I hope that is what happened and your wife is fine now. Also it is my understanding when the pd1s were in trial the patients once cleared were able to continue with the pd1 fine. I just had dose 15 of keytruda (Ie mk-3475) last week and have not experienced that side affect yet. Actually not much affects at all even the fevers I used to get I haven't in about 7 weeks which was part way through another batch of radiations. So I hope it is still working.
Artie
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- March 18, 2015 at 2:27 pm
Hi Eric,
I don't know if this cutting and pasting will work…but below is an article from 2013. Down in the fifth to last paragraph, the last sentence talks about Immune-related grade 1/2 pneumonitis occurring in 7 patients (5%). in the MK-3475 trial.
IPD-1 Inhibitor MK-3475 Again Shows Promise in Advanced Melanoma
MK-3475, an immunotherapy antibody against programmed death 1 (PD-1)—a key immune-checkpoint receptor expressed on some cancer cells—is continuing to show activity and long-term responses in patients with metastatic melanoma. The highest rate of objective response so far is 51% (51 patients) for those treated at the highest dose (10 mg/kg every 2 weeks), including 14% who experienced a complete response.
The overall response for all 116 patients treated at all 3 doses tested is 41%, including 9% experiencing a complete response. Eighty-eight percent of these responses are ongoing.
Results from the 116–melanoma patient cohort of a large multi-cancer phase I study were presented at the 10th International Congress of the Society for Melanoma Research (SMR), held November 17–20 in Philadelphia. A previous update of data from this patient cohort was presented at the American Society of Clinical Oncology annual meeting this summer. (See Combined Immunotherapies Show Promise in Metastatic Melanoma.)
The median duration of response at a median follow-up duration of 14.5 months has not yet been reached, according to presenter Caroline Robert, MD, head of dermatology at the Institut Gustave Roussy in Paris.
The 1-year survival rate is 81%, “an impressive rate of overall survival for a single-agent therapy,” said Robert.
Patients were treated with 10 mg/kg either every 2 or 3 weeks or with 2 mg/kg every 2 weeks. After a median follow-up of 14.5 months, 88% (43 patients) of the 49 responding patients continue to respond.
Twenty patients were treated at the lowest treatment dose of 2 mg/kg every 2 weeks. The response rate for these patients, who were all ipilimumab-naive, was 40%, with a 10% complete response rate.
The 24-week progression-free survival (PFS) rate was 54%. Those treated at the highest dose schedule had a 24-week PFS of 62%.
Durable responses to MK-3475 were seen both in ipilimumab-naive patients and in patients previously treated with ipilimumab. Seventy-five percent of the patients had a wild-type version of the BRAF gene and 22% had BRAF-mutated tumors. Fourteen percent of the patients had received three or more prior therapies.
“Most responses occur early in the treatment regimen, but patients also [had responses that] occurred beyond 6 months of treatment,” said Robert.
Most adverse events experienced by patients have been mild. The most common side effects were fatigue (37%), pruritus (26%), and rash (22%). Higher-grade drug-related adverse events were experienced by 13% of patients. High-grade adverse events were more frequent at the highest dosage schedule: 14 patients (25%) experienced a grade 3 or 4 adverse event. Immune-related grade 1/2 pneumonitis occurred in 7 patients (5%).
Robert noted that it is not clear why there is a difference in the rate of response for the highest dose of MK-3475 but that it will be necessary to understand how to best administer MK-3475, including knowing the optimal duration of treatment.
An ongoing three-arm phase III trial of MK-3475 in metastatic melanoma is comparing two different MK-3475 doses (10 mg/kg either every 2 or 3 weeks) to ipilimumab given at 3 mg/kg every 3 weeks.
MK-3475 has also recently shown activity in a cohort of patients with nonsquamous and squamous non–small-cell lung cancer (NSCLC) from the same phase I trial as the current melanoma patients.
Other anti–PD-1 and anti–PD-L1 agents, such as nivolumab and MPDL3280A, are also currently being tested in phase III trials, including the combination of two immunotherapy antibodies for metastatic melanoma patients.
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- March 18, 2015 at 2:27 pm
Hi Eric,
I don't know if this cutting and pasting will work…but below is an article from 2013. Down in the fifth to last paragraph, the last sentence talks about Immune-related grade 1/2 pneumonitis occurring in 7 patients (5%). in the MK-3475 trial.
IPD-1 Inhibitor MK-3475 Again Shows Promise in Advanced Melanoma
MK-3475, an immunotherapy antibody against programmed death 1 (PD-1)—a key immune-checkpoint receptor expressed on some cancer cells—is continuing to show activity and long-term responses in patients with metastatic melanoma. The highest rate of objective response so far is 51% (51 patients) for those treated at the highest dose (10 mg/kg every 2 weeks), including 14% who experienced a complete response.
The overall response for all 116 patients treated at all 3 doses tested is 41%, including 9% experiencing a complete response. Eighty-eight percent of these responses are ongoing.
Results from the 116–melanoma patient cohort of a large multi-cancer phase I study were presented at the 10th International Congress of the Society for Melanoma Research (SMR), held November 17–20 in Philadelphia. A previous update of data from this patient cohort was presented at the American Society of Clinical Oncology annual meeting this summer. (See Combined Immunotherapies Show Promise in Metastatic Melanoma.)
The median duration of response at a median follow-up duration of 14.5 months has not yet been reached, according to presenter Caroline Robert, MD, head of dermatology at the Institut Gustave Roussy in Paris.
The 1-year survival rate is 81%, “an impressive rate of overall survival for a single-agent therapy,” said Robert.
Patients were treated with 10 mg/kg either every 2 or 3 weeks or with 2 mg/kg every 2 weeks. After a median follow-up of 14.5 months, 88% (43 patients) of the 49 responding patients continue to respond.
Twenty patients were treated at the lowest treatment dose of 2 mg/kg every 2 weeks. The response rate for these patients, who were all ipilimumab-naive, was 40%, with a 10% complete response rate.
The 24-week progression-free survival (PFS) rate was 54%. Those treated at the highest dose schedule had a 24-week PFS of 62%.
Durable responses to MK-3475 were seen both in ipilimumab-naive patients and in patients previously treated with ipilimumab. Seventy-five percent of the patients had a wild-type version of the BRAF gene and 22% had BRAF-mutated tumors. Fourteen percent of the patients had received three or more prior therapies.
“Most responses occur early in the treatment regimen, but patients also [had responses that] occurred beyond 6 months of treatment,” said Robert.
Most adverse events experienced by patients have been mild. The most common side effects were fatigue (37%), pruritus (26%), and rash (22%). Higher-grade drug-related adverse events were experienced by 13% of patients. High-grade adverse events were more frequent at the highest dosage schedule: 14 patients (25%) experienced a grade 3 or 4 adverse event. Immune-related grade 1/2 pneumonitis occurred in 7 patients (5%).
Robert noted that it is not clear why there is a difference in the rate of response for the highest dose of MK-3475 but that it will be necessary to understand how to best administer MK-3475, including knowing the optimal duration of treatment.
An ongoing three-arm phase III trial of MK-3475 in metastatic melanoma is comparing two different MK-3475 doses (10 mg/kg either every 2 or 3 weeks) to ipilimumab given at 3 mg/kg every 3 weeks.
MK-3475 has also recently shown activity in a cohort of patients with nonsquamous and squamous non–small-cell lung cancer (NSCLC) from the same phase I trial as the current melanoma patients.
Other anti–PD-1 and anti–PD-L1 agents, such as nivolumab and MPDL3280A, are also currently being tested in phase III trials, including the combination of two immunotherapy antibodies for metastatic melanoma patients.
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- March 18, 2015 at 2:27 pm
Hi Eric,
I don't know if this cutting and pasting will work…but below is an article from 2013. Down in the fifth to last paragraph, the last sentence talks about Immune-related grade 1/2 pneumonitis occurring in 7 patients (5%). in the MK-3475 trial.
IPD-1 Inhibitor MK-3475 Again Shows Promise in Advanced Melanoma
MK-3475, an immunotherapy antibody against programmed death 1 (PD-1)—a key immune-checkpoint receptor expressed on some cancer cells—is continuing to show activity and long-term responses in patients with metastatic melanoma. The highest rate of objective response so far is 51% (51 patients) for those treated at the highest dose (10 mg/kg every 2 weeks), including 14% who experienced a complete response.
The overall response for all 116 patients treated at all 3 doses tested is 41%, including 9% experiencing a complete response. Eighty-eight percent of these responses are ongoing.
Results from the 116–melanoma patient cohort of a large multi-cancer phase I study were presented at the 10th International Congress of the Society for Melanoma Research (SMR), held November 17–20 in Philadelphia. A previous update of data from this patient cohort was presented at the American Society of Clinical Oncology annual meeting this summer. (See Combined Immunotherapies Show Promise in Metastatic Melanoma.)
The median duration of response at a median follow-up duration of 14.5 months has not yet been reached, according to presenter Caroline Robert, MD, head of dermatology at the Institut Gustave Roussy in Paris.
The 1-year survival rate is 81%, “an impressive rate of overall survival for a single-agent therapy,” said Robert.
Patients were treated with 10 mg/kg either every 2 or 3 weeks or with 2 mg/kg every 2 weeks. After a median follow-up of 14.5 months, 88% (43 patients) of the 49 responding patients continue to respond.
Twenty patients were treated at the lowest treatment dose of 2 mg/kg every 2 weeks. The response rate for these patients, who were all ipilimumab-naive, was 40%, with a 10% complete response rate.
The 24-week progression-free survival (PFS) rate was 54%. Those treated at the highest dose schedule had a 24-week PFS of 62%.
Durable responses to MK-3475 were seen both in ipilimumab-naive patients and in patients previously treated with ipilimumab. Seventy-five percent of the patients had a wild-type version of the BRAF gene and 22% had BRAF-mutated tumors. Fourteen percent of the patients had received three or more prior therapies.
“Most responses occur early in the treatment regimen, but patients also [had responses that] occurred beyond 6 months of treatment,” said Robert.
Most adverse events experienced by patients have been mild. The most common side effects were fatigue (37%), pruritus (26%), and rash (22%). Higher-grade drug-related adverse events were experienced by 13% of patients. High-grade adverse events were more frequent at the highest dosage schedule: 14 patients (25%) experienced a grade 3 or 4 adverse event. Immune-related grade 1/2 pneumonitis occurred in 7 patients (5%).
Robert noted that it is not clear why there is a difference in the rate of response for the highest dose of MK-3475 but that it will be necessary to understand how to best administer MK-3475, including knowing the optimal duration of treatment.
An ongoing three-arm phase III trial of MK-3475 in metastatic melanoma is comparing two different MK-3475 doses (10 mg/kg either every 2 or 3 weeks) to ipilimumab given at 3 mg/kg every 3 weeks.
MK-3475 has also recently shown activity in a cohort of patients with nonsquamous and squamous non–small-cell lung cancer (NSCLC) from the same phase I trial as the current melanoma patients.
Other anti–PD-1 and anti–PD-L1 agents, such as nivolumab and MPDL3280A, are also currently being tested in phase III trials, including the combination of two immunotherapy antibodies for metastatic melanoma patients.
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