OncoMed is halting clinical development of its anticancer come cell drug demcizumab (anti-DLL4, OMP-21M18) after a Phase II combination therapy study in front-line nonsquamous, non-small-cell lung cancer (NSCLC) failed to meet its primary endpoints.
The disappointing results come just weeks following the firm announced the failure of demcizumab in the Stage II YOSEMITE pancreatic cancer trial, the failure from the Phase II PINNACLE study evaluating the anti-Notch2/3 applicant tarextumab as combination therapy in small-cell lung malignancy, and partner Bayer’ s decision not to exercise the option to license the two Wnt pathway inhibitors vantictumab plus ipafricept. Last month, OncoMed reported that it would reduce its workforce by 50% to cut costs.
The failed Phase II DENALI study reported nowadays had been evaluating demcizumab in combination with carboplatin and pemetrexed, compared to placebo plus carboplatin and pemetrexed, as front-line treatment for nonsquamous NSCLC. The study had stopped enrolling in 82 out of a projected 200 patients due to exactly what OncoMed calls “ the evolving treatment landscape within NSCLC. ” Data from the 82 trial participants demonstrated that not only did the trial fail to meet the primary endpoint of overall response rate (ORR), yet that outcomes were better for patients in the placebo group than for those in the demcizumab treatment group. The particular ORR was 28% in the demcizumab group, compared with 52% in the placebo group, and the clinical benefit rate (a rate of complete and partial repsonses and steady free diseases) was 79% for the demcizumab group plus 92% of the placebo group, while median progression-free success rates were 5. 5 months and 8. seven months for the demcizumab and placebo arms, respectively.
OncoMed said it will now discontinue dosing many patients in demcizumab trials, including a Phase Ib study combining the drug with pembrolizumab, and will evaluation the program with partner Celgene.
Celgene plus OncoMed agreed to a $177. 25 up-front cash plus equity-based deal to jointly develop and commercialize as much as six anticancer stem cell products from the OncoMed pipeline, including demcizumab. The agreement, signed at the end of 2013, provided Celgene an exclusive option to license demcizumab during or following the completion of specific OncoMed-conducted Phase II studies. OncoMed may potentially have received option exercise, development, regulatory, and commercial obligations from Celgene of $790 million related to demcizumab growth.
Commenting on the firm’ s Q1 economic results and failure of the DENALI study, Paul M. Hastings, OncoMed’ s chairman and CEO, said the particular firm would continue to progress additional programs in the Celgene collaboration, which could result in $98 million in potential explicit opt-in payments during the next 2 years.
Confirming the firm’ s Q1 financial results, Hastings furthermore noted that the firm had cash and short-term assets of $156. 9 million, and would continue to create its immune-oncology anti-TIGIT (T-cell immunoreceptor with Ig plus ITIM domains) antibody candidate, its GITRL-Fc trimer, as well as other immune-oncology discovery programs. “ With more than 2 years cash, we have been dedicated to advancing our pipeline while exploring partnering for you to advance all of our programs. ”
A Stage Ia study with the anti-TIGIT candidate OMOP-313M32 was began last week in patients with advanced or metastatic strong tumors.