Abstract 2090
Background
AL 3818 (Anlotinib, Catequentinib) is a novel small molecule tyrosine kinase inhibitor that is administered orally. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of adding AL3818, to standard platinum-based plus/or paclitaxel chemotherapy in patients with recurrent or metastatic endometrial, ovarian or cervical carcinoma in Phase 1b/2a studies.
Methods
Patients with a diagnosis of recurrent or metastatic endometrial, ovarian, or cervical carcinomas requiring ≥ 2nd line treatment with standard platinum-based chemotherapy were eligible for enrollment on a 21 days cycle. In the Phase 1b study, after chemotherapy at Day 1, patients were started on Day 8 with daily AL 3818 at an initial dose of 12 mg for 14 days on a 21 day cycle. A 3 + 3 dose de-escalation design to 10mg, 8mg, and 6mg to determine the recommended Phase II dose (RP2D) was utilized. In the Phase 2a study, patients were treated with the RP2D in combination with either combination platinum based therapy or single agent paclitaxel based on origin of disease. 1st line endometrial patients are allowed. Maintenance monotherapy with AL3818 was given after chemotherapy stopped.
Results
In the Phase 1b study: (1) 9 subjects with recurrent or metastatic endometrial, ovarian or cervical carcinomas participated with RP2D determined; (2) common treatment emergent adverse event (TEAE) include abdominal pain), alopecia, anemia, arthralgia, asthenia, back pain, and constipation. Overall, most TEAEs were well tolerated by subjects. In Phase 1b and 2a studies: (1) the objective response rate (ORR) and disease control rate (DCR) were 58% and 79% for 19 evaluable endometrial subjects; (2) ORR and DCR were 50% and 93% for all 14 evaluable ovarian subjects; (3) 48 subjects with recurrent or metastatic endometrial, ovarian, and cervical carcinoma were enrolled in the Phase 2a study.
Conclusions
AL3818 has demonstrated positive combined synergic efficacy with standard platinum-based plus/or paclitaxel chemotherapy in both endometrial and ovarian cancer patients.
Clinical trial identification
NCT02584478.
Editorial acknowledgement
Legal entity responsible for the study
Advenchen Laboratories, LLC.
Funding
Advenchen Laboratories.
Disclosure
Z. Li: Full / Part-time employment: Advenchen laboratories. M. Chen: Full / Part-time employment: Advenchen laboratories. J. Chen: Full / Part-time employment: Advenchen laboratories. All other authors have declared no conflicts of interest.
Resources from the same session
5747 - The routine use of sentinel lymph node biopsy in high risk DCIS lesions is not justified
Presenter: Fanny Preat
Session: Poster Display session 2
Resources:
Abstract
1837 - Oncological impact of re-excision for positive margin status after breast conserving surgery in invasive breast cancer
Presenter: Kenjiro Jimbo
Session: Poster Display session 2
Resources:
Abstract
4347 - Pneumonitis and fibrosis after breast cancer radiation.
Presenter: Jarle Karlsen
Session: Poster Display session 2
Resources:
Abstract
2280 - Prognosis of mastectomy with reconstruction after neoadjuvant chemotherapy: a nationwide study in Korean Breast Cancer Society
Presenter: Sungmin Park
Session: Poster Display session 2
Resources:
Abstract
804 - A negative prognosis of radiotherapy-induced lower lymphocyte to monocyte ratio in patients with breast cancer
Presenter: Chang-ik Yoon
Session: Poster Display session 2
Resources:
Abstract
2701 - Patient data to monitor clinical patterns in early and advanced breast cancer in Europe
Presenter: Francesco Giusti
Session: Poster Display session 2
Resources:
Abstract
1437 - A critical appraisal of quality indicators of breast cancer treatment in Belgium
Presenter: Didier Verhoeven
Session: Poster Display session 2
Resources:
Abstract
1534 - Predictors of adherence among post-menopausal women receiving adjuvant endocrine therapy for breast cancer in Ontario, Canada
Presenter: Phillip Blanchette
Session: Poster Display session 2
Resources:
Abstract
4363 - Evaluation of endocrine therapy and patients preferences in early breast cancer: results of Elena study
Presenter: Emilia Montagna
Session: Poster Display session 2
Resources:
Abstract
2679 - Baseline Quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): the French multicentric prospective CANTO cohort study
Presenter: Idlir Licaj
Session: Poster Display session 2
Resources:
Abstract