Anti-PD-1 Immunotherapy Clinical Trial Update

Portal Forums Lung/Thoracic Cancer NSCLC Stage IV NSCLC Anti-PD-1 Immunotherapy Clinical Trial Update

This topic contains 46 replies, has 14 voices, and was last updated by  wendyp 10 months, 1 week ago.

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August 18, 2012 at 6:35 am  #1246967    

FeistyD

Update on my anti-PD-1 clinical trial (MK 3475): I had my twelve-week scans this week. Everyone, including the doctors, trial nurses, and my family and friends, was very anxious to see the results, as I am the first of the lung cancer arm to get my scans at my clinic. And….ta da, almost seventy percent shrinkage of my tumors with no new mets! I had a feeling the results would be good, because I just feel better.
I feel normal, like my old, pre-cancer self. No side effects so far, no nausea, no thyroid or liver problems, and my hair is growing back. Most of all, I have hope! I love modern medicine! Clinical trials save lives!
:-P

August 18, 2012 at 6:51 am  #1246970    

certain spring

That is seriously nice news, Feisty D, and worthy of your name. Thank you for the update.
Must be quite strange to have everyone jumping up and down to see your scans!
I was wondering if you ever came across Justtina – you and she were discussing the trial on an earlier thread?

http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/

Hope you continue to feel better.


49-year-old non-smoker, dx stage IV NSCLC May 2010 (squamous tumour of the left lung with multiple brain metastases). Radiotherapy to chest and brain; progressed through two cycles carbo/gemcitabine. Repeated lung collapses; pneumonia in collapsed lung, Nov 2010; bronchial stent placed, Dec 2010. Declined second-line Taxotere. Mutation testing Feb 2011, surprise EGFR exon deletion 19. Started Tarceva (150mg), Feb 2011. Progression in liver and elsewhere, May 2013.

August 18, 2012 at 7:15 am  #1246971    

catdander forum moderator

FeistyD, That is seriously good news. I’m so impressed with you and our other members for taking advantage of testing these new drugs.
Ta Da indeed!
Janine


My husband, 53 @ dx of stage 3 squam nsclc R. pancoast tumor 8/09 caused destruction of 3 ribs, touching brachial plexus. 2 core and 1 VATS undx biopsies. Open thoracotomy for 1 positive biopsy (unresectable). Chemorads, 9/09. MRI by pancoast specialty surgeon 11/09 spine met found, stage IV, Rad to spine, Chemo changed from cis/etop to navelbine/carbo. 6 cycles total. Tarceva 2/10-11/10. 3cm tumor L lung, biopsy undx w/collapsed lung. Gemzar, 12/10 through 7/12. NED 3/12, stop tx 7/12. Remains NED as of 8/14.

August 18, 2012 at 2:28 pm  #1246997    

Dr West

That’s remarkable, and it’s extremely encouraging for you and as a lead for how someone with spindle cell/sarcomatoid lung cancer, a pretty rare subtype, might be treated effectively. I’m very happy for you and hope this is a great lead for many other people as well.

-Dr. West


Howard (Jack) West, MD
Medical Oncologist

Views expressed here represent my opinion, not those of GRACE or Swedish Cancer Institute. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

August 19, 2012 at 3:01 am  #1247024    

Jazz

WOW!! That’s great news! Very thrilled for you! Long may you run on this trial. Please keep us posted!

Jazz


Non-smoker, Dx 6/06 Stage IV Adeno. EGFR+ (exon 19 del), T790m+. Trial: 2cyc Carbo/Doce/Avastin + 2 w/Gem 8 – 12/06; Avastin maint. 1 – 4/07. Alimta + Tarceva 5/07 – 2/09. NED to 8/09. Tarceva 150 9/09-5/11, SBRT/XRS to lung & spine met 2/11. Trial MK2206 (AKT inhibitor) + Tarceva 5 – 12/11. Afatinib+cetuximab trial 2/12 -2/13. LL collapsed. 1/13 PET – new bone & adrenal mets. 4 cyc Carbo-Gem-Tarceva 5/13. Brain MRI 10/13 – clear. Lost Dad to LC 5/13.Anti-PDL1@Angeles Clinic?

August 19, 2012 at 12:18 pm  #1247060    

graceabchen

It is exciting to have a real example of excellent response of this rare form of nsclc in the anti-PD-1 clinical trial. Although anti-PD-1 Immunotherapy was a big news from this year’s ASCO, the data for nsclc were just average. The objective response rate was 18% (14 of 76 patients), as reported at http://www.nejm.org/doi/full/10.1056/NEJMoa1200690 . I have an impression that Immunotherapy works best in the maintenance setting. May be this phase of trial will push it to the first line. I also notice that this trial also includes the anti-PD-1+tarceva subset. This will open a new window for the EGFR+ patients. I did not see the trial criteria exclude patients who have acquired TKI resistance. Will these patients qualify for the trial? More importantly, can this combination actually treat the acquired resistance?

August 19, 2012 at 7:39 pm  #1247069    

Dr West

I don’t know answers to those questions at this time…I believe that Bristol-Myers Squibb is still clarifying their future research priorities and plans.

-Dr. West


Howard (Jack) West, MD
Medical Oncologist

Views expressed here represent my opinion, not those of GRACE or Swedish Cancer Institute. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

August 19, 2012 at 7:52 pm  #1247072    

ssflxl

Hello,

I am unable to find this clinical trial on MK 3475 in US – only available in Australia in the clinicaltrials.gov website. Is there any difference between this and BMS?

thanks

ssflxl


Non smoker Asian F, St 4 NSCLC – 11/2010, 6 cm LUL mass, met to paraspinal muscle, +EGFR at Exon 21 L858R. Tarceva in 11/2010, rad to lung mass and met. 5/2012 – PET showed inc SUV in primary cancer, new 1.6 cm lesion in left thoracic inlet causing Horner’s syndrome. Cyberknife to lesion – 5/2012. Restarted Tarceva 75mg/day -5/12, reduced to 50mg. 8/12 – PET- thoracic inlet lesion gone. 11/12 PET – inc SUV in primary tumor, ant mammary node, some SUV uptake in a fibrotic area in apex. Biopsy of this showed fibrosis and scant atypical cell. Cyberknife to mammary node, continue Tarceva. PET-10/13 – incr SUV to 14 in left primary tumor and new 1cm nodule in LUL, no new symptom. 12/13 – biopsy of LUL- same Exon 21, L858R – ?no T790M. on Tarceva 75/50. 1/14 PET – not much change. 2/14 – arm pain, cough, sob. CT – inc tumor to 5.55.9 with LUL collapse. 2/14 – Carbo/Pem x6. 4/14 PET – dec SUV but new bony lesions. PET in 6/14 – stable. start Pem every 3 wks in 7/14, Pamidronate every 6 wk.

August 19, 2012 at 8:24 pm  #1247073    

FeistyD

I heard the Merck trial will be reopening with new arms combining anti-PD-1 with chemotherapy for melanoma and NSCLC.
I don’t know about the difference between the BMS and the Merck anti-PD-1 drugs, but I believe they are quite similar. I’m just a survivor, though, not a biochemist or oncologist. You should really ask an expert.

August 19, 2012 at 10:37 pm  #1247075    

Jazz

Ssflxl,

FeistyD is enrolled in the Merck trial at the Angeles clinic in LA. Her trial doesn’t seem to be recruiting any longer however it does appear that the MDX-1105 (also known as BMS936559) trial is recruiting there. The difference is that it’s an anti-PD-L1 trial, which is trying to inhibit the ligand… See Dr. Brahmer’s explanation in the podcast on immunotherapies – it’s the other side of the coin of the anti-PD1 therapy.

This doesn’t answer your question as to what the difference is, but thought you or someone else may be interested in this. Usually the difference is the actual molecule (like the difference between Iressa and Tarceva), otherwise the companies would be fighting over patenting it.

As I mentioned to blue skies on her thread, the phase 1 trials at johns Hopkins (BMS936558 + Tarceva or avastin or certain doublets) filled up as soon as they opened…

Jazz


Non-smoker, Dx 6/06 Stage IV Adeno. EGFR+ (exon 19 del), T790m+. Trial: 2cyc Carbo/Doce/Avastin + 2 w/Gem 8 – 12/06; Avastin maint. 1 – 4/07. Alimta + Tarceva 5/07 – 2/09. NED to 8/09. Tarceva 150 9/09-5/11, SBRT/XRS to lung & spine met 2/11. Trial MK2206 (AKT inhibitor) + Tarceva 5 – 12/11. Afatinib+cetuximab trial 2/12 -2/13. LL collapsed. 1/13 PET – new bone & adrenal mets. 4 cyc Carbo-Gem-Tarceva 5/13. Brain MRI 10/13 – clear. Lost Dad to LC 5/13.Anti-PDL1@Angeles Clinic?

August 19, 2012 at 11:27 pm  #1247077    

ssflxl

Dear Jazz,

thanks for your comments. I have already put the BMS trial into my folder for future considerations. It’s good to hear from FeistyD of such good result with the drug.

ssflxl


Non smoker Asian F, St 4 NSCLC – 11/2010, 6 cm LUL mass, met to paraspinal muscle, +EGFR at Exon 21 L858R. Tarceva in 11/2010, rad to lung mass and met. 5/2012 – PET showed inc SUV in primary cancer, new 1.6 cm lesion in left thoracic inlet causing Horner’s syndrome. Cyberknife to lesion – 5/2012. Restarted Tarceva 75mg/day -5/12, reduced to 50mg. 8/12 – PET- thoracic inlet lesion gone. 11/12 PET – inc SUV in primary tumor, ant mammary node, some SUV uptake in a fibrotic area in apex. Biopsy of this showed fibrosis and scant atypical cell. Cyberknife to mammary node, continue Tarceva. PET-10/13 – incr SUV to 14 in left primary tumor and new 1cm nodule in LUL, no new symptom. 12/13 – biopsy of LUL- same Exon 21, L858R – ?no T790M. on Tarceva 75/50. 1/14 PET – not much change. 2/14 – arm pain, cough, sob. CT – inc tumor to 5.55.9 with LUL collapse. 2/14 – Carbo/Pem x6. 4/14 PET – dec SUV but new bony lesions. PET in 6/14 – stable. start Pem every 3 wks in 7/14, Pamidronate every 6 wk.

August 19, 2012 at 11:29 pm  #1247078    

certain spring

There was an earlier discussion of comparable trials here:

http://cancergrace.org/lung/topic/pd-1-clinical-studies-bms-vs-mk/


49-year-old non-smoker, dx stage IV NSCLC May 2010 (squamous tumour of the left lung with multiple brain metastases). Radiotherapy to chest and brain; progressed through two cycles carbo/gemcitabine. Repeated lung collapses; pneumonia in collapsed lung, Nov 2010; bronchial stent placed, Dec 2010. Declined second-line Taxotere. Mutation testing Feb 2011, surprise EGFR exon deletion 19. Started Tarceva (150mg), Feb 2011. Progression in liver and elsewhere, May 2013.

December 8, 2012 at 3:55 am  #1251079    

certain spring

FeistyD, inquiries are being made on another thread as to how you are getting on?

http://cancergrace.org/topic/afatinib-cetuximab-trial-user-group/page/6/#post-1251077

Hope all is well and you are still getting good results from the trial. Very best.


49-year-old non-smoker, dx stage IV NSCLC May 2010 (squamous tumour of the left lung with multiple brain metastases). Radiotherapy to chest and brain; progressed through two cycles carbo/gemcitabine. Repeated lung collapses; pneumonia in collapsed lung, Nov 2010; bronchial stent placed, Dec 2010. Declined second-line Taxotere. Mutation testing Feb 2011, surprise EGFR exon deletion 19. Started Tarceva (150mg), Feb 2011. Progression in liver and elsewhere, May 2013.

December 8, 2012 at 8:52 am  #1251087    

FeistyD

Thanks for asking- I’m still here! I have done 10 infusions of MK 3475 so far. My second set of scans in October showed continued shrinkage of my lung tumors and no new mets. I have my third set of scans next week (brain MRI and CT scans), so I’ll let you know how those go. My side effects have been minor- some itchy red spots on my legs and hand, some muscle pain, and some fatigue. I’m still working full-time and trying to keep fit. I imagine they are examing my blood tests and scans pretty closely to see why I am doing so well. I have no known mutations, which may actually be a factor in my response. The doctor asked me last time if I had been a smoker (I was 30 years ago, for a few years in high school/college), which may also be a factor. Most importantly, my tumors express PD-L1. What a difference a year makes- last year I was bald, and could barely walk. Here I am, getting ready for Christmas and going to the gym!

December 8, 2012 at 8:56 am  #1251088    

catdander forum moderator

That’s great! The last sentence is the best. I look forward to more excellent updates!


My husband, 53 @ dx of stage 3 squam nsclc R. pancoast tumor 8/09 caused destruction of 3 ribs, touching brachial plexus. 2 core and 1 VATS undx biopsies. Open thoracotomy for 1 positive biopsy (unresectable). Chemorads, 9/09. MRI by pancoast specialty surgeon 11/09 spine met found, stage IV, Rad to spine, Chemo changed from cis/etop to navelbine/carbo. 6 cycles total. Tarceva 2/10-11/10. 3cm tumor L lung, biopsy undx w/collapsed lung. Gemzar, 12/10 through 7/12. NED 3/12, stop tx 7/12. Remains NED as of 8/14.

December 8, 2012 at 8:59 am  #1251089    

certain spring

How wonderful. Thanks for responding.
It is a very nice thing to confound people’s expectations, and one’s own!


49-year-old non-smoker, dx stage IV NSCLC May 2010 (squamous tumour of the left lung with multiple brain metastases). Radiotherapy to chest and brain; progressed through two cycles carbo/gemcitabine. Repeated lung collapses; pneumonia in collapsed lung, Nov 2010; bronchial stent placed, Dec 2010. Declined second-line Taxotere. Mutation testing Feb 2011, surprise EGFR exon deletion 19. Started Tarceva (150mg), Feb 2011. Progression in liver and elsewhere, May 2013.

December 8, 2012 at 8:40 pm  #1251120    

Dr West

Great to hear! Thanks for the encouraging update.

-Dr. West


Howard (Jack) West, MD
Medical Oncologist

Views expressed here represent my opinion, not those of GRACE or Swedish Cancer Institute. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

December 8, 2012 at 10:59 pm  #1251132    

Jazz

Sounds like a Merry Christmas to you, Feisty! We love this news. Best of luck with next week’s scans.

The high dose (10mg) sounds like it’s working for you. I wonder if there are other NSCLC folks doing alright on the lower doses?

The expanded trial sounds fairly complicated, with randomization to either low, medium, or high dose WITH standard chemo (doesn’t mention what agent), or anti-PDL-1 low or high dose. So I imagine testing would be done for PD-1 expression prior to randomization to the anti-PDL-1 arm? Perhaps you can probe your Doc as to what chemo agents might be used in combination? Inquiring minds want to know…

Jazz


Non-smoker, Dx 6/06 Stage IV Adeno. EGFR+ (exon 19 del), T790m+. Trial: 2cyc Carbo/Doce/Avastin + 2 w/Gem 8 – 12/06; Avastin maint. 1 – 4/07. Alimta + Tarceva 5/07 – 2/09. NED to 8/09. Tarceva 150 9/09-5/11, SBRT/XRS to lung & spine met 2/11. Trial MK2206 (AKT inhibitor) + Tarceva 5 – 12/11. Afatinib+cetuximab trial 2/12 -2/13. LL collapsed. 1/13 PET – new bone & adrenal mets. 4 cyc Carbo-Gem-Tarceva 5/13. Brain MRI 10/13 – clear. Lost Dad to LC 5/13.Anti-PDL1@Angeles Clinic?

December 9, 2012 at 6:24 am  #1251140    

FeistyD

Jazz, You have a lot of good questions. I do not feel qualified to answer. My study doesn’t involve chemo at this point. I know the DRUG in my study is anti-PD-1, and the TUMOR expresses anti-PD-L1 (not the other way around). From your signature it looks like you are in California. Why don’t you call the Angeles Clinic and talk to one of the the study nurses? 310-582-7900. They are much better qualified to answer your questions.
I also heard from my former onc that City of Hope and USC Norris will be offering anti-PD-1 trials soon, too. If you are in California you have many options. Good luck!

December 21, 2012 at 6:43 am  #1251658    

FeistyD

I got the results from my latest scans yesterday. My primary lung tumors continue to shrink at a steady pace of a couple of millimeters every checkup (scans every 9 weeks). After six months on anti-PD-1, they are down to 0.7 X 1.6 cm and 1.4 X 1.3 cm. As a comparison, a year ago, after chemo, they were 2.1 X 1.9 and 3.2 X 2.7. The brain MRI was normal. My doctors feel I will continue to respond; basically, I am “on autopilot” as far as my treatment goes. I feel great with minor side effects of some joint/muscle pain and itchy red spots on my hands and legs. My docotr says the response rate is about 20%, so I feel very, very fortunate to have found this clinic and this trial. I would probably not be writing this if I hadn’t.

New arms of the Merck trial are open/opening, so if you are interested, let me know.

Merry Christmas to all!

  • This reply was modified 1 year, 10 months ago by  FeistyD.
  • This reply was modified 1 year, 10 months ago by  FeistyD.
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