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Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

4088 - Randomized phase 3 ANGEL study of rivoceranib (apatinib) + best supportive care (BSC) vs placebo + BSC in patients with advanced/metastatic gastric cancer who failed _2 prior chemotherapy regimens

Date

29 Sep 2019

Session

Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

Presenters

Yoon-Koo Kang

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

Y. Kang1, W.K. Kang2, M. Di Bartolomeo3, I. Chau4, H.H. Yoon5, S. Cascinu6, M. Ryu7, J.G. Kim8, K. Lee9, S.C. Oh10, A. Takashima11, A. Kryzhanivska12, Y. Chao13, V. Vladimirov14, L. Evesque15, M. Schenker16, A. McGinn17, N. Sankar18, L. Wyrwicz19, N. Boku20

Author affiliations

  • 1 Oncology, Asan Medical Center, 05505 - Seoul/KR
  • 2 Hematology-oncology, Samsung Medical Center, Seoul/KR
  • 3 Medical Oncology, Fondazione IRCCS-Istituto Nazionale Tumori, Milan/IT
  • 4 Medical Oncology, Royal Marsden Hospital, London/GB
  • 5 Oncology, Mayo Clinic Cancer Center, Rochester/US
  • 6 Oncology/hematology, Università di Modena e Reggio Emilia, Modena/IT
  • 7 Oncology, Asan Medical Center, Seoul/KR
  • 8 Oncology/hematology, Kyungpook National University Chilgok Hospital, Daegu/KR
  • 9 Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam/KR
  • 10 Medical Oncology, Korea University Guro Hospital, Seoul/KR
  • 11 Medical Oncology, National Cancer Center Hospital, Tokyo/JP
  • 12 Medical Oncology, Communal Institution Ivano-Frankivsk Regional Oncological Center, Ivano-Frankivsk/UA
  • 13 Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 14 Medical Oncology, State Budgetary Healthcare Institution of Stavropol Territory Pyatigorsk Oncology Dispensary, Pyatigorsk/RU
  • 15 Medical Oncology, Institut Gustave Roussy, Nice Cedex/FR
  • 16 Medical Oncology, Centrul de Oncologie ‘Sf. Nectarie’, Sectia de Oncologie Medicala, Craiova/RO
  • 17 Business And Product Development, LSK BioPharma, Salt Lake City/US
  • 18 Clinical Development, LSK BioPharma, Salt Lake City/US
  • 19 Medical Oncology, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej, Warsaw/PL
  • 20 Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo/JP
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Resources

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Abstract 4088

Background

Rivoceranib is an oral, selective tyrosine kinase inhibitor of VEGFR-2 with demonstrated efficacy for gastric cancer in China. ANGEL was a global phase III study to evaluate the efficacy and safety of rivoceranib in gastric cancer.

Methods

Main eligibility criteria included advanced/metastatic adenocarcinoma of the stomach or gastroesophageal junction after failure of ≥ 2 prior lines of chemotherapy; ECOG PS ≤ 1. Patients were stratified by geographic region (Asia vs North America/Europe), disease measurability, prior ramucirumab use, and treatment therapy line (3rd or ≥ 4th), and randomized (2:1 ratio) to rivoceranib 700 mg qd po or matched placebo with BSC until disease progression, intolerable toxicity or withdrawal of consent. Primary endpoint: overall survival (OS, ITT population). Secondary endpoints: progression-free survival (PFS); objective response rate (ORR); disease control rate (DCR); quality of life (QoL); safety. Clinical trial registration: NCT03042611.

Results

Overall, 460 patients (rivoceranib n = 308, placebo n = 152) were enrolled from Feb 2017 – Oct 2018. Baseline demographics were balanced. While mOS in ≥ 3rd-line patients did not show statistical difference for rivoceranib vs placebo (5.78 vs 5.13 mo; HR = 0.93; 95% CI 0.74–1.15; p = 0.4850), mPFS was significantly improved with rivoceranib (2.83 vs 1.77 mo; HR = 0.57; 95% CI 0.46–0.79; p < 0.0001), as was ORR (6.87% vs 0%; p = 0.0020) and DCR (42.37% vs 13.08%; p < 0.0001) in patients with measurable lesions. Furthermore, in ≥ 4th-line patients (rivoceranib n = 122, placebo n = 63) mOS (6.43 vs 4.73 mo; HR = 0.65; 95% CI 0.46–0.92; p = 0.0195) and mPFS (3.52 vs 1.71 mo; HR = 0.38; 95% CI 0.27–0.53; p < 0.0001) were significantly improved with rivoceranib vs placebo. Treatment was generally well tolerated; the most common treatment-related AEs were hypertension (34%) and hand-foot syndrome (26%).

Conclusions

While OS was not significantly improved in the overall population, most other efficacy endpoints including OS in ≥ 4th-line suggest that rivoceranib has a benefit and is well tolerated in patients with gastric cancer.

Clinical trial identification

NCT03042611.

Editorial acknowledgement

Lee Miller, Miller Medical Communications Ltd.

Legal entity responsible for the study

LSK BioPharma.

Funding

LSK BioPharma.

Disclosure

Y. Kang: Advisory / Consultancy: ONO; Advisory / Consultancy: BMS; Advisory / Consultancy: Daehwa; Advisory / Consultancy: LSK Biopharma; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Macrogenics; Advisory / Consultancy: Zymeworks; Advisory / Consultancy: Blueprint; Advisory / Consultancy: Merck Serono; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Astellas; Research grant / Funding (institution): Roche. M. Di Bartolomeo: Honoraria (self), Speaker Bureau / Expert testimony: Lilly spa; Honoraria (self), Speaker Bureau / Expert testimony: Servier; Honoraria (self), Speaker Bureau / Expert testimony: Merck-Serono; Honoraria (self), Speaker Bureau / Expert testimony: MSD; Travel / Accommodation / Expenses: Roche spa; Travel / Accommodation / Expenses: Sanofi. I. Chau: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli-Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Merck-Serono; Advisory / Consultancy: Five Prime Therapeutics; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Oncologie International; Advisory / Consultancy: Pierre Fabre; Research grant / Funding (institution): Janssen-Cilag; Research grant / Funding (institution): Sanofi Oncology. H.H. Yoon: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Merck; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): LSK; Honoraria (institution), Advisory / Consultancy: BeiGene; Advisory / Consultancy: FivePrime Therapeutics; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution): Genetech/Roche; Research grant / Funding (institution): Boston Biomedical. S. Cascinu: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Speaker Bureau / Expert testimony: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly. M. Ryu: Honoraria (self), Advisory / Consultancy: ONO; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Taiho; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Daehwa. K. Lee: Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self): Eli Lilly; Research grant / Funding (institution): ALX Oncology; Research grant / Funding (institution): Array BioPharma; Research grant / Funding (institution): ASLAN Pharmaceuticals; Research grant / Funding (institution): AstraZeneca/MedImmune; Research grant / Funding (institution): Five Prime Therapeutics; Research grant / Funding (institution): Green Cross Corp.; Research grant / Funding (institution): LSK BioPharma; Research grant / Funding (institution): Macrogenics; Research grant / Funding (institution): Merck KGaA; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Ono Pharmaceutical; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Pharmacyclics. A. McGinn: Shareholder / Stockholder / Stock options, Full / Part-time employment: LSK BioPharma. N. Sankar: Shareholder / Stockholder / Stock options, Full / Part-time employment: LSK BioPharma. N. Boku: Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Eli Lilly; Honoraria (self): Chugai. All other authors have declared no conflicts of interest.

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