Information on projected release dates, FWIW - 1265612

biggerten
Posts:83

I found this a few months ago, been of two minds whether to post it or not. I decided I will and more informed folks can decide whether it's worthwhile or not. Note: MK-3475 is now known as pembrolizumab.

The below list of anticipated launch dates for each of the leading PD-1/PD-L1 products across melanoma, non-small-cell lung cancer and renal cell carcinoma (source: Goldman Sachs) demonstrates, however, why analysts expect nivolumab to emerge as the leading product by 2020. Next year will be a critical one for Bristol-Myers Squibb as it looks to position nivolumab as an integral component in the treatment of NSCLC.

The calendar also provides a tangible reminder that despite a certain amount of bluster about the competitiveness of this race, AstraZeneca and Roche are not likely to launch their products before late 2016, over two years from now. There is much to play for and, as Goldman Sachs analysts note themselves, current regulatory timelines are likely to accelerate if more impressive data is generated.
______________________________
2014 – MK-3475 for metastatic melanoma (2nd line [Yervoy-refractory] melanoma)
______________________________
Mid-2015 – nivolumab for NSCLC (3rd line squamous)
H2 2015 – nivolumab for NSCLC (2nd line squamous)
H2 2015 – nivolumab for NSCLC (2nd line non-squamous)
______________________________
H1 2016 – MK-3475 for metastatic melanoma (2nd line)
Mid-2016 – nivolumab for metastatic melanoma (1st and 2nd line)
Mid-2016 – MK-3475 for PD-L1-positive NSCLC
H2 2016 – nivolumab for RCC (2nd line)
Late 2016 – MPDL3280A for NSCLC (2nd and 3rd line)
Late 2016 – MEDI-4736 for PD-L1-positive NSCLC (3rd line)
______________________________
Mid-2017 – nivolumab + Yervoy in melanoma
Late 2017 – MPDL3280A + Avastin on RCC (1st line)
______________________________
H1 2018 – nivolumab + Yervoy in RCC
H1 2018 – nivolumab + Yervoy in NSCLC
H1 2018 – MEDI-4736 in NCSLC (2nd line, stage III

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Reply # - August 28, 2014, 09:00 AM

JimC
Posts: 2753

Tom,

Thanks for posting that information. As you say, readers can judge for themselves what to make of it. In addition to the Goldman Sachs comment that "current regulatory timelines are likely to accelerate if more impressive data is generated", I would also state that it's also possible for those drug launches to be delayed if less-than-impressive data emerges.

The information you share also provides a good example illustrating how frustratingly slow the drug development process can be.

JimC
Forum moderator

Reply # - January 12, 2015, 08:30 AM

biggerten
Posts: 83

Bristol Myers Squibb Opdivo vs docetaxel Phase III study in squamous cell nsclc has been halted early due to Opdivo's superiority. Wonderful news. I'll bet Bristol Myers has an FDA application waiting on a rocket pad ready to send off as soon as they can find a match to light the fuse.

While this doesn't affect my wife Lucy's adenocarcinoma directly, it certainly adds hope.

I am happy today for those who will be helped by this progress.

Here's a link I hope works -

http://www.businessweek.com/news/2015-01-12/bristol-myers-shares-gain-o…

Reply # - January 12, 2015, 08:59 PM

Dr West
Posts: 4735

Yes, very exciting, and I hope and expect that in not too long we'll soon get a similar press release about their companion trial done in non-squamous NSCLC. More importantly, we should hope to see Opdivo (nivolumab) approved and commercially available for patients with previously treated advanced NSCLC, whether squamous or non-squamous before too long.

-Dr. West

Reply # - February 27, 2015, 01:07 PM

biggerten
Posts: 83

FDA has accepted BMS application for Opdivo, in squamous NSCLC, third line. Deadline for action is June 22nd. Seems likely it will be available soon for that indication.

Reply # - February 27, 2015, 01:10 PM

Dr West
Posts: 4735

Thanks for the follow up.

I heard some passing reference among a few lung cancer specialists to there being hope of getting approval around the time of the big ASCO conference in the last days of May/beginning of June. It was earlier than I expected to see an approval. Nothing legally binding there, just a recognition that there is always a lot of activity in the cancer world right around that time.

-Dr. West

Reply # - March 4, 2015, 11:41 AM

biggerten
Posts: 83

That was quick. FDA has approved nivolumab (Opdivo) for use in squamous NSCLC. Three business days since they accepted the application.

Reply # - March 4, 2015, 06:18 PM

sawcmw
Posts: 41

Does anyone know if BMS has, or is getting ready to submit an application for nivolumab to the FDA for NSCLC adenocarcinoma? Same for Merck regarding Keytruda?

Steve

Reply # - March 4, 2015, 06:32 PM

Dr West
Posts: 4735

BMS is definitely planning to submit nivolumab (Opdivo) for non-squamous NSCLC, but unlike the squamous NSCLC trial, which was found to show a significant survival difference in January during a planned interim analysis, the non-squamous trial is still ongoing. Presumably, the differences are less dramatic or both arms are just doing so well that the results are still cooking. But there's good reason to be hopeful that an approval for non-squamous NSCLC will come later.

In the meantime, given the cost of Opdivo, I doubt payers will cover it for use outside of the specific population named in the approval, namely patients with metastatic squamous NSCLC who have already received platinum-based chemotherapy.

-Dr. West

Reply # - March 4, 2015, 06:41 PM

phillydaughter
Posts: 44

Yes that is my question too
When for adenocarcinoma?
I heard they work better in smokers? Any truth. Mom quit 25 yrs ago and has a adeno.
after 4 carbo/ alimta and 3 month "break" to recover, she is now progressing. Yikes!
So no to maintenance. Doc offered tarceva( but she is KRAS) or docetaxel. Instead I found checkmate 153 for nivolumab trial. Meeting to see if eligible next week.
Tom what is ur wife considering?
Are we better off to get for free under trisl( praying we qualify) or hope for approval ( will Medicare cover)?

Why did squamous have only 272 patients with half on Nivo.
Checkmate 153 is both types and enrolled 272 and now taking 500 more. It will b a while for these results since still enrolling.
What would b the number of the adenocarcinoma trial that may have results sooner?

Reply # - March 5, 2015, 05:20 AM

biggerten
Posts: 83

I have no special knowledge to offer, I just Google this stuff a lot. One can see that things are moving fast, faster than people thought.

Merck said in January that they expect to file a BLA for Keytruda by mid year for NSCLC, we'll see. ASCO is at the end of May, I'd bet they're aiming to make a splash, but this Opdivo news may speed things a bit, who can say?

I also don't understand everything, but I recently read where Roche is perhaps considering some early action on MPDL3280A, but it's rumor only.

I tend to see this kind of information more on financial sites, it seems there are more people interested in money than in cancer. Go figure.

Reply # - March 5, 2015, 07:28 AM

phillydaughter
Posts: 44

I also find a lot on financial sites.
I would be interested to hear what your wife's current treatment is? And your decision for choosing such? We are confused and at a crossroads. Thinking to go for trial over docetaxel or Tarceva.
If you are on Inspire you can find me there. I don't want to clog up this site with questions meant for the docs. Otherwise not sure how to reach you.
I have also done lots research and willing to share.
Michelle

Reply # - March 6, 2015, 05:36 AM

biggerten
Posts: 83

In response to a question posed on another thread, as of this very moment Lucy has no treatment. We are waiting for the oncologist's recommendation.

I don't know whether to expect WBR or stereotactic. I would expect follow on chemo consisting of pemetrexed (Alimta).

Hopefully that will put out the immediate fire and get us to a steady state once again, and maybe some immunotherapy down the road.

I know it is discouraged to hope for one line over another, but the indications that MPDL3280A showed some elevated response rates in smokers/former smokers (Lucy quit in 1988). I had my fingers crossed.

It looks like one or more of the PD-1 drugs will be available later this year. The PD-L1 drugs (MPDL3280A and MEDI4736) are a bit beyond that.

So, we take today, and hope for tomorrow. And hope for good news out of ASCO.

Reply # - April 19, 2015, 10:00 AM

biggerten
Posts: 83

And now Merck has filed for approval of Keytruda in advanced NSCLC.

Response rates seem particularly high when PD1 expression is greater than 50% on a proprietary test, which was also put forth for approval.

http://www.reuters.com/article/2015/04/19/us-merck-co-cancer-lung-idUSK…

The paper was published in the New England Journal of Medicine.

http://www.nejm.org/doi/full/10.1056/NEJMoa1501824?query=featured_home

Dr. West's post postulates Opdivo approval in the next month or two, since the approval for Opdivo in squamous NSCLC was apporximately seven weeks from trial stoppage.

So, it looks like another two arrows in Lucy's oncologist's quiver soon.

Also, Genentech has made noises about filing for MPDLA3280A approval 'within the coming year', that's a PD-L1 drug.

Looks like these agents are coming in 6 months to a year quicker than the info in my post from last August.

Of course I pray these will aid my wife, but regardless they should help many people.

These are single agent approvals, there are many, many ongoing combination trials (and against other cancers), and other immune pathways under study.

A humble thank you to all the researchers, medical staff and patients who have taken this effort so far, so fast. Lucy and I are living on hope, please keep feeding us.

Reply # - June 16, 2015, 01:22 PM

biggerten
Posts: 83

I have come across information that NCCN has updated their guidelines to include Nivolumab in both squamous and non-squamous NSCLC, second line. Apparently, this is notable because they are leaving the gate, so to speak, before the FDA in regards to non-squamous NSCLC.

I have tried to verify this, but the NCCN site with the information for clinicians is behind a paywall.

Can anyone verify this? Does it mean that it is now standard of care, or at least approaching it?

The FDA has accepted Merk's sBLA application for Keytruda in adeno NSCLC, they are committed to a response by early October, discussion remains over labeling, PD-1 testing, etc. They have partnered with a test outfit (Avago, IIRC) who has also applied for test approval.

By the way, MPDL3280A from Roche (PD-L1, as opposed to Opdivo and Keytruda's PD-1 mechanism) has picked up a new moniker, it's now known as atezolizumab, for those interested.

I know Dr. West has elsewhere referenced the differences between PD-1 drugs as perhaps Coke versus Pepsi, with the PD-L1 drugs maybe being 7-UP.

I'll be encouraging Lucy to drink more soda. :wink:

Reply # - June 16, 2015, 01:46 PM

phillydaughter
Posts: 44

During last month's ASCO I found this:
http://www.onclive.com/conference-coverage/asco-2015/Phase-III-Data-Sho…
it says "BMS has applied for an additional indication in the nonsquamous setting..."

My mom is adeno and receiving nivolumab (7 infusions so far)on the Checkmate 153 trial. 40% shrinkage per the trial criteria. The last three months have been a miracle for us.
How is Lucy? What is her current status?
I am on Inspire. If you are, message me at Phillydaughter and I can share more.
My husband is involved with building BMS's new site in Dublin which will manufacture nivo and ipi. Exciting stuff.

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