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2017 ASCO Annual Meeting!

Session: Gynecologic Cancer

Type: Poster Session

Time: Saturday June 3, 1:15 PM to 4:45 PM

Location: Hall A

Clinical activity of the selective DRD2 antagonist ONC201, an imipridone, in metastatic endometrial cancer (mEC).

Uterine Cancer

Gynecologic Cancer

2017 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #414)

J Clin Oncol 35, 2017 (suppl; abstr 5592)

Author(s): Lorna Rodriguez-Rodriguez, Janice M. Mehnert, Ann W. Silk, Nancy Chan, Jyoti Malhotra, Joseph Aisner, Tracie Saunders, Bangning Yu, Siobhan Dickerson, Rohinton Tarapore, Joshua E. Allen, Martin Stogniew, Wolfgang Oster, Howard Kaufman, Bruce George Haffty, Joseph R. Bertino, Mark N. Stein; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Oncoceutics, Philadelphia, PA

Abstract Disclosures


Background: mEC is a generally incurable, with limited therapeutic options. ONC201 is the founding member of the new class of compounds called imipridones that are orally active small molecules. ONC201 a specific antagonist of the G protein-coupled receptor DRD2 exerts antitumor activity via a series of established signaling pathways (dual inhibition ERK/AKT, integrated stress response). DRD2 expression is elevated in malignant versus normal endometrial tissue. Furthermore ONC201 has shown anti-cancer activity in preclinical models of EC. Methods: In a Phase I trial that included an expansion cohort, a total of 28 evaluable patients (pts) were treated with ONC201 at doses from 125mg every 3 weeks to 625 weekly. Five of these patients had advanced mEC. Results: The median age for the mEC patients was 60 years (56-72), the median number of prior treatments was 5 (3-6), 3 patients had prior radiation and all patients had prior surgery. One patient received 375mg ONC201 while the other 4 patients received 625mg ONC201, orally every 3 weeks. The median number of doses was 3 (2-14). Two of 5 patients exhibited regressions in individual metastatic lesions, however they did not qualify as overall objective responses by RECIST criteria. One of these two patients experienced stable disease for 42 weeks. There were no reported SAEs and no Grade > 1 AEs attributed to study drug. Conclusions: ONC201 is clinically active and well tolerated with oral administration in refractory mEC patients. Clinical trial information: NCT02250781

ONC201 (mg)375mg625mg625mg625mg625mg
HistologyClear cell
(Type II)
Endometrioid (Type I)Poorly differentiated
(Type II)
(Type II)
Endometrioid (Type I)
Time on study (weeks)7.417.742.96.38.9
Tumor responseMixed ResponseStable DiseaseStable Disease (Lung regression)Progressive DiseaseProgressive Disease
Tumor DRD2 expression+++N/AN/A

Other Abstracts in this Sub-Category:


1. Final results of the international randomized PORTEC-3 trial of adjuvant chemotherapy and radiation therapy (RT) versus RT alone for women with high-risk endometrial cancer.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5502 First Author: Stephanie M. De Boer
Category: Gynecologic Cancer - Uterine Cancer


2. A randomized phase III trial of docetaxel plus cisplatin or paclitaxel plus carboplatin compared with doxorubicin plus cisplatin as adjuvant chemotherapy for endometrial cancer at high risk of recurrence: Japanese Gynecologic Oncology Group study (JGOG2043).

Meeting: 2017 ASCO Annual Meeting Abstract No: 5503 First Author: Hiroyuki Nomura
Category: Gynecologic Cancer - Uterine Cancer


3. A randomized phase III trial of cisplatin and tumor volume directed irradiation followed by carboplatin and paclitaxel vs. carboplatin and paclitaxel for optimally debulked, advanced endometrial carcinoma.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5505 First Author: Daniela Matei
Category: Gynecologic Cancer - Uterine Cancer