MEDI4736

This topic contains 69 replies, has 19 voices, and was last updated by  mickh 5 months ago.

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November 13, 2013 at 9:18 am  #1260483    

mrkenney

I just found this website and this forum while searching for information on Anti-PD-L1 so I thought I’d weigh in here if you don’t mind.

I just started on the Phase1 trial of MedImmune’s foray into the immunobiology race. The trial is named MEDI4736 and while it’s the new kid in town it’s showing the same potential as the trials from Merck and Roche. Or at least the lab rats at Cambridge think so. :-)

I’m a 52 year old male. Smoked for 30 years and I’ve always been on the bigger side of life so I fell into the perfect mixture for Esophageal Cancer. Thankfully we found it before it got to the point of causing any issues with swallowing but unfortunately it has already metastasized to the liver. I had 5 treatments of Folfox6 which according to my oncologist I was not handling as well as he’d like.

I’ve had 2 infusions of MEDI4736 and the only side effect so far was sleeping like a bear the evening of the first infusion. No nausea, very minor lethargy, no pain or any form of neuropathy and thankfully no cold sensitivity. Whether this drug is actually doing anything is yet to be seen but quality of life is back to being a 10.

I have one more treatment next Monday and then go back in for a liver biopsy and CT Scan the week of Thanksgiving. Hopefully we’ll have lots to be thankful for.

Peace,
Mike

November 13, 2013 at 11:47 am  #1260486    
catdander forum moderator
catdander forum moderator

Hi Mike!

Thanks so much for introducing us/me to the new drug in the anti pd-l1 race. I hope you don’t mind but I pasted a link to the search results from clinicaltrials.org to MEDI4736 not knowing if any of the 3 is the one your on. I’ll plan on hearing good news from you for Thanksgiving.

http://clinicaltrials.gov/ct2/results?term=MEDI4736+&Search=Search

Welcome to Grace and please keep us posted.
Janine

November 13, 2013 at 8:08 pm  #1260492    
Dr West
Dr West

That’s great to hear. We would LOVE to learn of another potentially very effective, well tolerated anti-cancer therapy that has the promise of working well in many different cancer types. Please share your experiences, hopefully a great success, but we’ll be very interested no matter what.

Good luck.

-Dr. West

November 14, 2013 at 11:26 pm  #1260525    

laya d.

Thank you so much for letting us know. . .and best of luck to you on your upcoming scan!

Laya


1/10 – My Mom (58) dx w/ NSCLC-Adeno 3a; 1 cycle of neoadjuvent Carbo/Alimta before finding out EGFR+ (Ex. 19), then switched to 7 wks of neoadjuvent Tarceva/150 mg (major shrinkage); 4/10 – right pneumonectomy; 6/10 started 3 rounds of adjuvent Cis/Alimta w/ concurrent chest radiation (7 wks); 8/10 – NED; 11/10 – small nodule in left lung; 1/11 – 3 small nodules in left lung, start Tarceva/100 mg; 4/11 – suspected sclerotic met to hip, continue w/ Tarceva, add XGEVA, brain MRI clear; 9/11 – solitary 3 cm met (adeno w/ T790m mutation) to cerebellum, surgery and gamma knife, up Tarceva to 150 mg; 11/11 – 2 left lung nodules growing, biopsy on 1 shows mutation from adeno to squamous (shocker!), brain MRI clear, continue Tarceva & Xgeva; 2/12 – brain MRI clear, CT scan, remaining nodule slightly bigger – – monitor for now, Tarceva (reduced to 100 mg) & Xgeva continued; 4/12 progression and rebiopsy (confirmed adeno), stop Tarceva, switch to Carbo/Alimta; 6/12 maintenanceAlimta; 8/12 back to Tarceva; 10/12 Gemzar; 11/16 difficulty breathing; 12/12 hospice initiated…my Mom passed away peacefully on 12/19/12. Heartbroken.

February 10, 2014 at 11:50 am  #1262213    

Bill

Hi Mike,

I’m on your blog now….and as you know, I’m now in the process of being screened for the MEDI-4736 trial at Memorial Sloan Kittering in NYC.

Here is the trail description:

http://clinicaltrials.gov/ct2/show/NCT01693562

Bill Drake

February 11, 2014 at 6:38 am  #1262232    

mrkenney

Just a quick update for anyone coming across this post. I just had treatment number 9 yesterday of the MEDI4736. That means I’ve been off of chemo for over 5 months and I’ve been on this for just over 4. Last Friday I had a CT Scan and they compared it to the baseline scan.

The radiologists impression was: “Stable exam. No evidence of disease progression.”

While my oncologist was hesitantly optimistic he had a pretty darn big grin on his face when he gave me the news.

February 11, 2014 at 7:11 am  #1262233    
JimC Forum Moderator
JimC Forum Moderator

Stable is great…no wonder he was smiling! And so are we! Thanks for sharing your good news.

JimC
Forum moderator


Jul 2008 Wife Liz (51/never smoker) Dx Stage IV NSCLC EGFR exon 19
4 cycles Carbo/alimta, 65% shrinkage
Tarceva maintenance
Mar 2010 progression, added Alimta, stable
Sep 2010 multiple brain mets, WBR
Oct 2010 large pericardial effusion, tamponade
Jan 2011 progression, start abraxane
Jun 2011-New liver, brain mets, add Tarceva
Oct 2011-Dx Leptomeningeal carcinomatosis; pulsed Tarceva
At rest Nov 4 2011
Since then: http://cancergrace.org/blog/jim-and-lisa

February 11, 2014 at 7:13 am  #1262234    

Bill

Great Mike!

Good to talk to you yesterday….I will keep you posted on my progress at Sloan.

February 11, 2014 at 7:18 am  #1262235    

mrkenney

Also for those of you who have asked me directly, my dosage is 10mg/kg and that is given via IV over a 1 hour period. My understanding is that this was the maximum level that had been set for the escalation period of phase1 and since there has been almost no noted side effects that is now the prescribed amount.

February 11, 2014 at 4:25 pm  #1262243    

Dr. Ben Creelan

Sounds exciting, let’s hope for the best. We would know very little about cancer if not for courageous and hopeful participants on clinical trials, like you.

February 11, 2014 at 5:24 pm  #1262248    
catdander forum moderator
catdander forum moderator

mrkenney, Stable makes me cautiously smiley. I’ve heard of some people having progression then shrinkage on some of the immuno drugs.
Congrats for stable and the lack of side effects.
Best,
Janine

June 23, 2014 at 6:54 am  #1264523    

Bill

Mike,

How’s it going?

Bill

June 23, 2014 at 11:33 am  #1264526    

mrkenney

Hey Bill,

It’s going amazingly well. I had my 18th treatment of MEDI4736 last Monday and so far I’m still not experiencing any side effects. More importantly is that my last 2 CT Scans came back with no discernible cancer found. My oncologist even had all of my past scans reviewed again at one time to verify the radiologists summary and that was the final conclusion. Needless to say my oncologist is as elated as I am.

The current course is to complete the one year round of medication, which will take me to mid October and then sit back and see what happens. The desired outcome is that my immune system will continue to fight the cancer on it’s own.

At this point they don’t know how to categorize my condition. They don’t believe it’s a cure as they feel the cancer is still present. They also don’t want to call it remission because they don’t believe the cancer is dormant. So I’m in the big question mark category at the moment which is quite alright by me.

I’ve also been in contact with a lady in TX whose father is on this trial and is also starting to show signs of improvement. His diagnosis was very similar to mine although it had progressed further and he’s also a good 20 years older than me. But his appetite and weight have returned and he’s getting some energy back that he’d lost so it’s sounding very promising.

June 23, 2014 at 1:43 pm  #1264532    
catdander forum moderator
catdander forum moderator

Wow, great news mrkenney, Congratulations! I hope to hear NED or whatever it’s called continues on well past Oct.

Bill, did you ever get into the trial?

Janine

June 23, 2014 at 6:41 pm  #1264536    
Dr West
Dr West

Great to hear! Thanks for the update.

-Dr. West

June 23, 2014 at 6:45 pm  #1264538    

ssflxl

mrkenney,

Were you tested for PDL 1 prior to entering this trial? if so, are you positive for PDL 1?
congratulations for the great response.

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 5.5×5.9 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.

July 2, 2014 at 5:59 am  #1264723    

Bill

Hi Mike,

I’m trying to get in a trail, #NCT01975831 study in Boston at Dana Farber with MEDI4736 in combination with Tremelimumab. It’s being run by Dr. Patrick Ott. The trail is also being done at MSKCC in NY with Dr. Maggie Callahan.

I have have been receiving Docetaxel – 6 infusions so far. Not any real side effects except loss of hair. My last scan showed that the lymph nodes have not been growing, and no mets.

I would love to connect with you again by phone. here is my email:

bdrake103@gmail.com

– Bill

July 2, 2014 at 6:16 am  #1264724    

Bill

Dr. West,
Question: I had some of my cancer tissue (extracted on Sept 11, 2013) tested for PDL1 at Medimmune as part of my screening for a MEDI4736 trail at MSKCC. I have requested their report on the test, but have been told that because it was testing for a trial, and was done blind, and I can’t get a report. The trial Doc at MSKCC, Dr. Segal was called with the result — negative. I have learned that the test is not 100% conclusive, and that the tissue needs to be fresh. I just want to ask what you think of this situation.
Thanks, Bill

July 2, 2014 at 7:36 am  #1264726    

mrkenney

Bill et al,
My first liver biopsy for the PD-L1 testing was a bust and I had to have another scheduled. Obviously I wasn’t thrilled with this news and wanted a better understanding. My oncologist explained that while the surgeon has a good idea of where the tumor(s) is getting a sample is still a bit of a hit or miss proposition, and even when they do get a sample it doesn’t mean that it’s enough for testing.

I don’t know what my studies protocol requires as far as percentage of PD-L1 expression from the biopsy but from talks at the ASCO conference my oncologist heard of positive results in patients that had “very little” signs of PD-L1. Of course I know that was a dumbed down comment, I guess the question is how sure are they that your cancer isn’t expressing PD-L1 or how much needs to be seen in testing in order to meet the trials protocols?

Another anti-PD-L1 drug that’s now in phase II is from Roche MPDL3280A and is being tested against bladder cancer. I don’t know if they are going to branch out to studying this with other cancers but it sounds like another one to check out.

July 2, 2014 at 8:03 am  #1264727    

Bill

Mike – thanks for the info! So after all, you did test positive for the PD-L1? Did Medimmue do the testing? Bill

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