A Study of MK-8109 (Vintafolide) Given Alone or With Chemotherapy in Participants With Advanced Cancers (MK-8109-001)
This study is ongoing, but not recruiting participants.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 17, 2012
Last updated: July 17, 2014
Last verified: July 2014
Estimated Enrollment: 94
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
I noticed more recruiting locations. I guess they have completed Dosing (PART A) and now they are moving ahead with (PART B) therefore more recruiting locations.
It appears this study is going very well based on recent update July 16, they are anticipating more than 30 patients rather than just 30. It has been almost 7 months. I think news is coming soon.
Merck Rejection entirely based on different reason.
1. Ofcourse Ovarian failure - No immediate money to make. But, commitments for TNBC, NSCLC trials.
2. Their own product for NSCLC. Anti-PD-1. That is first line of treatment
What is different about NSCLC vs Ovarian
1. Docetaxel is different drug then Doxil.
2. Ovarian cancer is different from NSCLC
Vintafolide is all about targeted therapy, it is entirely possible that Doxil is already working better with or without targeted approach, therefore failure. But, same may not be true for Docetaxel. Docetaxel may be more potent with targeted approach hence significant PFS improvement and OS. If they have achieved PFS hurdle for Phase-II NSCLC, they will certainly achieve OS end point.
22 PT is well calculated and should occur in two months. It is certainly true that OS for NSCLC is around 13 to 14 months compared to 9 months. New partnership should be in works, they withdraw triple Negative breast cancer. They dont want to spend single dime without partner. I believe they are negotiating new partners for sure.
Lilly intends to submit the first application of these data to regulatory authorities in the second half of 2014..
If Lilly is successful then the new Bar (10.5) months is set. If Endocyte crosses that Bar then Lilly will seriously consider to do partnership or buyout to continue dominance.
My logic is if endocyte met PFS target then they should achieve OS target as well. Near term target 15 is sure target if the OS is inline with expectation.
"not expect much premium even if they do a deal". ECYT set bar for NSCLC 2b so high, reaching primary end point itself is big thing. PFS 7.1 months vs PFS 3.5months (most recent Eli lilly study). For endocyte OS will be in range of 13 to 15 monts. OS for Docetaxel alone is 9.1 months, recent Eli lilly improved OS to 10.1 months in Phase-III study.
See below Data for Eli lilly drug. There are no drugs even little closer to Endocyte. I would easily expect full sponsorship of Phase-3 trial of NSCLC and around two to three hundred m payment with Royalty.
Patients treated on the CYRAMZA-plus-docetaxel arm (n=628) achieved a median OS of 10.5 months compared to 9.1 months for patients on the placebo-plus-docetaxel arm (n=625). The OS hazard ratio was 0.86 (95% CI, 0.751-0.979, p=0.023), which corresponds to a 14 percent reduction in risk of death.
Median PFS was 4.5 months on the CYRAMZA-plus-docetaxel arm compared to 3.0 months on the placebo-plus-docetaxel arm, with a PFS hazard ratio of 0.76 (p
Merck left because no immediate money to make in Endocyte. + They have their own NSCLC (immune based solution to kill cancer cells). Merck is so smart they just put 120m upfront and wanted to make immediate money if Ovarian was successful. But, now commitment is longer and they have their own competing drug. Recent Eli Lilly study showed 9.1 to 10.5 OS improvement with PFS (3.5 something) so poor compare to EC145 (7.1 months) . EC145 is trending towards 3 months extra OS. I looked everywhere to see if there are any better competitor for NSCLC but there is none. Big thing about ECYT drug is super low toxicity since it is targeted therapy. All others have more toxicity when increased dose. Also, from merck side it is strategic shift to focus on Hep c. I dont think ECYT is doomed at all. It just basically we are back to Phase-2b instead of Phase-3 --drug approval. Target 15 is reasonable once Phase-3 begins with new partnership.
One should read EC1456 Pre-clinical. They cured mice that did not relapse. In my experience I have seen several drug preclinical testing where subject always relapse after sometime but not cured permanently. Looking closely NSCLC data of previous phase 2study where PFS is 7.1 months, never seen something like that. Also, warhead comparison PLD vs Docetaxel and No reason to believe Ovarian and NSCLC outcome will be same. They know that they can precisely target foliate receptor expressing cells.
Guaranteed buyer to fuel next Rally. If this does not breakdown today then it is certainly destined to cross 7.70 in next couple weeks. Rounded bottom and stock not crashing is clear sign for going up. Fundamentally they have superb technology.
More likely OS will be 12 months so buying season should begin now. Merck will be convinced to sponsor for Phase-3 for anything above 11months OS.
In short conclusion is that if 9.1 months was by end of March for docetaxel in Phase-2 then it is almost two months. It could easily pass Lily's OS Data of 10.5 months. Also, it is better than Lily's 14% vs 25 % EC145.