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Poster session 16

1229P - A multicenter phase II study of sotigalimab (CD40 agonist) in combination with neoadjuvant chemoradiation for resectable esophageal and gastroesophageal junction (GEJ) cancers

Date

10 Sep 2022

Session

Poster session 16

Topics

Immunotherapy

Tumour Site

Oesophageal Cancer;  Gastro-Oesophageal Junction Cancer

Presenters

Andrew Ko

Citation

Annals of Oncology (2022) 33 (suppl_7): S555-S580. 10.1016/annonc/annonc1065

Authors

A.H. Ko1, M. Noel2, J. Chao3, D. Sohal4, M. Crow5, P.E. Oberstein6, A. Scott7, A. McRee8, C. Rocha Lima9, L. Fong10, B. Keenan10, E. Filbert11, F.J. Hsu11, V. Shankaran12

Author affiliations

  • 1 Medical Oncology, UCSF - University of California San Francisco - Parnassus Campus, 94143 - San Francisco/US
  • 2 Medical Oncology, Georgetown University, 20007 - Washington/US
  • 3 Department Of Medical Oncology And Therapeutics, City of Hope Comprehensive Cancer Center, 91010 - Duarte/US
  • 4 Medical Oncology, University of Cincinnati Cancer Centre, 45219 - Cincinnati/US
  • 5 Medical Oncology, Renovatio Clinical, Houston/US
  • 6 Medical Oncology, NYU Langone Health - Perlmutter Cancer Center - 34th Street, 10016 - New York/US
  • 7 Medical Oncology, University of Arizona Cancer Center, 85724-5024 - Tucson/US
  • 8 Medical Oncology, University of North Carolina - Chapel Hill, 27514 - Chapel Hill/US
  • 9 Medical Oncology, Wake Forest University Comprehensive Cancer Center, 27103 - Winston-Salem/US
  • 10 Medicine Department, UCSF - University of California San Francisco, 94143 - San Francisco/US
  • 11 Clinical Research, Apexigen Inc., 94070 - San Carlos/US
  • 12 Medical Oncology, University of Washington Seattle Cancer Care Alliance, 98109-4405 - Seattle/US
More

Abstract 1229P

Background

Neoadjuvant chemoradiation (CRT) followed by surgical resection is a standard approach for patients (pts) with locally advanced esophageal/GEJ cancers. A pathologic complete response (pCR) is achieved in 22-23% of adenocarcinomas (AC) and 42-49% of squamous cell carcinomas (SCC) and is associated with improved survival outcomes. Sotigalimab (sotiga) is a high affinity, potent CD40 agonist mAb capable of inducing and expanding anti-tumor immune responses by activating dendritic cells (DCs), T cells, NK cells, B cells, and M1 macrophages. This study examined the safety and efficacy of combining sotiga with neoadjuvant CRT in pts with esophageal/GEJ cancers.

Methods

Pts with resectable (T1-3, Nx) AC or SCC of the esophagus/GEJ were eligible. T1N0 and cervical tumors were excluded. Study treatment: carboplatin (AUC 2)/paclitaxel (PTX) (50 mg/m2) weekly x 5 with radiation 5040 cGy plus up to 4 doses of sotiga 0.3mg/kg IV prior to Ivor-Lewis esophagectomy. Primary efficacy endpoint was pCR.

Results

34 pts were enrolled (safety pop). Histology: 76% AC, 24% SCC; clinical stage: II/III/IVA, 9%/68%/23%; location: GEJ 47%. AEs (> 20%) attributed to sotiga: nausea, chills, fatigue, cytokine release syndrome (CRS), pyrexia, vomiting, abnormal LFTs, thrombocytopenia, diarrhea, and pruritus; majority Grade 1-2. Grade >3 CRS was observed in 3 pts (9%). No pt withdrawals due to sotiga; no treatment-related deaths. 28 pts were evaluable for the primary endpoint (3 opted against surgery, 1 pt withdrew after PTX reaction, 1 unrelated death, 1 surgery still pending). Path responses: 10 pCR (36%), 16 pPR (57%), 18 major path resp (<10% residual tumor) (64%). 2 PD (7%), ORR 93%. pCR by histology: 7/23 AC (30%), 3/5 SC (60%). Post-tumor samples demonstrated increased infiltration and activation of DCs and monocytes compared to baseline.

Conclusions

Sotiga combined with neoadjuvant chemoradiation for esophageal/GEJ cancers was generally well tolerated and achieved pCR rates in both AC and SCC that compare favorably to historical data and are promising for this treatment strategy. Additional evaluations of clinical outcomes (including DFS, OS) and immune-based biomarkers are ongoing.

Clinical trial identification

NCT03165994.

Editorial acknowledgement

Legal entity responsible for the study

Apexigen, Inc.

Funding

Apexigen, Inc.

Disclosure

A.H. Ko: Financial Interests, Personal, Other, Member of Data Monitoring Committee: Imugene, Erytech, Roche/Genentech, Ipsen; Financial Interests, Personal, Other, Developed content for web-based platform as well as lecture materials on pancreatic cancer; speaker at multiple CME activities: Clinical Care Options; Financial Interests, Personal, Other, Member and now chair of Pancreatic Cancer Task Force: National Cancer Institute; Financial Interests, Institutional, Invited Speaker, Local PI for clinical trial (pancreatic cancer): Celgene, Roche/Genentech; Financial Interests, Institutional, Invited Speaker, Local PI for clinical trial (esophageal cancer): Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker, National PI for clinical trial (GI cancers): Abgenomics; Financial Interests, Institutional, Invited Speaker, National PI for clinical trial (esophageal cancer): Apexigen; Financial Interests, Institutional, Invited Speaker, Local PI for clinical trial (gastric cancer): Leap Therapeutics, Astellas; Non-Financial Interests, Other, MemberMultiple prior committee/speaking roles for Annual MeetingAssociate Editor: American Society of Clinical Oncology; Non-Financial Interests, Sponsor/Funding, For Precision Promise clinical trials consortium. Funding paid directly to my institution.: Pancreatic Cancer Action Network; Non-Financial Interests, Sponsor/Funding, For clinical trials collaboration. Funding paid directly to my institution.: Parker Institute for Cancer Immunotherapy. M. Noel: Financial Interests, Personal, Advisory Role: Celgene, Taiho Pharma, Ipsen; Financial Interests, Personal, Speaker’s Bureau: Celgene, Taiho Pharma, Daiichi Sankyo/ AstraZeneca; Financial Interests, Institutional, Funding: Apexigen. J. Chao: Financial Interests, Personal, Advisory Role: Lilly, Merck, AstraZeneca, Daiichi Sankyo, Ono Pharma, Bristol Myers Squibb, Astellas Pharma, Turning Point Thera, Roche, Silverback Thera, Novartis, Coherus Biosciences, Geneos; Financial Interests, Personal, Advisory Role, +travel: Foundation Medicine, Macrogenics, Amgen; Financial Interests, Personal, Speaker’s Bureau, +travel: Merck; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Institutional, Funding: Merck, Novonco Thera, Brooklyn Immunotherapeutics, Apexigen. D. Sohal: Financial Interests, Personal, Advisory Role: Perthera, Ability Pharma, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Incyte, Genentech; Financial Interests, Personal, Other, Honoraria: Foundation Medicine; Financial Interests, Institutional, Funding: Celgene, Genentech, Bristol-Myers Squibb, Incyte, Rafael Pharma, Apexigen, Amgen, Ability Pharma, AstraZeneca, FibroGen, Merck. M. Crow: Financial Interests, Personal, Funding: Merck, Incyte, Janssen; Financial Interests, Institutional, Funding: Apexigen. P.E. Oberstein: Financial Interests, Personal, Advisory Role, +travel: Merck; Financial Interests, Personal, Advisory Role: Rubius Thera, QED Thera, AstraZeneca, Delcath Systems; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Expert Testimony: Ipsen; Financial Interests, Institutional, Funding: Merck, Roche/Genentech, Rafael Pharma, Arcus BioSciences. A. Scott: Financial Interests, Personal, Advisory Role, +travel: Exelixis, QED Pharma; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Stocks/Shares: Johnson johnson; Financial Interests, Personal, Funding: Exelixis, Genentech, Incyte, Five Prime, Merck; Financial Interests, Institutional, Funding: Apexigen. A. McRee: Financial Interests, Personal, Full or part-time Employment, recent move to industry: Janssen; Financial Interests, Personal, Stocks/Shares: Johnson Johnson; Financial Interests, Institutional, Funding: Inovio Pharma, Novartis, Merck, Boston Biomedical, AstraZeneca, Rgenix, BioMed Valley Discoveries, Takeda. C. Rocha Lima: Financial Interests, Personal, Funding: Rafael Pharma, Boston Biomedical, Pharmacyclics; Financial Interests, Institutional, Funding: Apexigen. L. Fong: Financial Interests, Personal, Stocks/Shares: Actym, Allector, Atreca, Bioatla, Bolt, Immunogenesis, Nutcracker, RAPT, Scribe, Senti, Soteria, TeneoBio; Financial Interests, Personal, Ownership Interest: Keyhole; Financial Interests, Institutional, Funding: Abbvie, Bavarian Nordic, Dendreon, Janssen, Merck, Roche/Genentech; Financial Interests, Personal and Institutional, Funding: BMS; Financial Interests, Institutional, Invited Speaker: Corvus; Financial Interests, Personal, Funding: AstraZeneca, Merck KGA. B. Keenan: Financial Interests, Institutional, Funding: Partner Therapeutics. E. Filbert: Financial Interests, Personal, Full or part-time Employment: Apexigen; Financial Interests, Personal, Stocks/Shares: Apexigen. F.J. Hsu: Financial Interests, Personal, Full or part-time Employment: Apexigen; Financial Interests, Personal, Officer: Apexigen. V. Shankaran: Financial Interests, Personal, Other, Honoraria: Cambia Health Foundatio; Financial Interests, Institutional, Funding: Amgen, Merck, Bayer, Bristol Myer Squibb, AstraZeneca, Genentech/Roche, Apexigen.

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