SITC cancer immunotherapy resource document: a compass in the land of biomarker discovery.

Since the publication of the Society for Immunotherapy of Cancer's (SITC) original cancer immunotherapy biomarkers resource document, there have been remarkable breakthroughs in cancer immunotherapy, in particular the development and approval of immune checkpoint inhibitors, engineered cellular therapies, and tumor vaccines to unleash antitumor immune activity. The most notable feature of these breakthroughs is the achievement of durable clinical responses in some patients, enabling long-term survival. These durable responses have been noted in tumor types that were not previously considered immunotherapy-sensitive, suggesting that all patients with cancer may have the potential to benefit from immunotherapy. However, a persistent challenge in the field is the fact that only a minority of patients respond to immunotherapy, especially those therapies that rely on endogenous immune activation such as checkpoint inhibitors and vaccination due to the complex and heterogeneous immune escape mechanisms which can develop in each patient. Therefore, the development of robust biomarkers for each immunotherapy strategy, enabling rational patient selection and the design of precise combination therapies, is key for the continued success and improvement of immunotherapy. In this document, we summarize and update established biomarkers, guidelines, and regulatory considerations for clinical immune biomarker development, discuss well-known and novel technologies for biomarker discovery and validation, and provide tools and resources that can be used by the biomarker research community to facilitate the continued development of immuno-oncology and aid in the goal of durable responses in all patients.
Competing Interests: Competing interests: SHL – Consulting: Amgen, Merck, Genmab, Xencor, Bristol-Myers Squibb, Regeneron; Funding support: Bristol-Myers Squibb, Merck, Vaccinex; Contracted research: Astellas, Merck, Xencor, Boehringer Ingelheim, Kite Pharma, Vedanta. SB – Employee: Roche Tissue Diagnostics. SG – Funding: Bristol-Myers Squibb, Rexahn, Incyte, Novartis, LSK BioPharma, Five Prime, Mirati, QED Bioscience, Debiopharm, Merck, Pfizer, AstraZeneca, MedImmune, Clovis, and Immunocore; Spouse stock ownership: Salarius Pharmaceuticals. BAH – Research funding: Merck, GlaxoSmithKline, Tempest Therapeutics, Leap Therapeutics, A*STAR Singapore, Sanofi; Consulting fees: Novartis, Merck, G1 Therapeutics. SJ – President and owner: ZellNet Consulting, Inc. TOK – Owner: Biolab Services; Employee: Immodulon Therapeutics. YK – Travel funds: AgonOx, Beckman Coulter; Consulting: Curiox; Research and travel funding: Shimadzu Corporation; Research funding from Bristol-Myers Squibb. YDM – President and owner: FlowKnowHow LLC; Business relationship ZellNet Consulting, Inc. RDN – Shareholder: Eli Lilly, Bristol-Myers Squibb. TS – Employee: Regeneron; IP rights: Regeneron; Sockholder: Regeneron. HTM – Scientific advisory board: Cytek, Inc., Caris Life Sciences; Stockholder: BD Biosciences; Spouse employed by: AbbVie Inc. KD, JCJBG, AWL, CM, SRS, YZ – Nothing to disclose. SITC Staff: AK, BL, LL, RL, SMW – Nothing to disclose.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)