Drug development in oncology is historically challenging, exhibiting a very high attrition rate, with low rates of approval for novel treatments when compared to other therapeutic areas. At present, along with the advent of novel targeted agents and immunotherapeutic strategies, designs, and aims of early-phase clinical trials in oncology have radically changed, switching from exploring safety to integrating more ambitious efficacy endpoints. Prognostic scoring systems specifically addressing outcomes of patients treated in early phase clinical trials testing novel immunotherapeutic agents are strongly needed, helping clinicians to identify who might actually benefit from trial recruitment. Last but not least, novel classes of immunotherapeutic strategies, such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy, and their combinations with immune-checkpoint inhibitors (and immunomodulatory antibodies against novel check-points), present with a new set of adverse events, requiring specific management and an adaptive trial design, for example accounting for late-onset toxicities and permitting interim dose decisions on the basis of partial toxicity information.
The goal of the present Research Topic is to acquire better knowledge and insight into the most recent advances in early-phase clinical trials assessing novel immunotherapeutic agents. Specifically, we aim to:
1. Investigate how to refine the trial design in order to improve efficiency in the drug development pathway.
2. Define patient selection at study enrolment, maximizing therapeutic intent (e.g.: optimizing prognostic scores based on clinical, pathological, and molecular variables).
3. Tackle the implementation of pharmacodynamics markers for novel immunotherapeutic anti-cancer agents
4. Gain expertise in the management of treatment-related adverse events emerging with the experimental use of next-generation immunotherapeutic agents such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy and their combinations with other immunomodulatory agents or standard anticancer (chemotherapy, radiotherapy, targeted therapy).
We welcome the submission of the following article types:
- Case Reports describing exceptional toxicities and their management when testing novel immunotherapeutic agents such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy, and their combinations with immune-checkpoint inhibitors (and immunomodulatory antibodies against novel check-points).
- Review Articles providing concise and precise updates on the latest progress made in the field of early-phase immunotherapeutic drug development; reviews are meant to identify gaps and controversies, and provide new perspectives and critical evaluation of current knowledge and methodology.
- Original Research Articles reporting clinical trials that involve early stages of drug development of novel immunotherapeutic anti-cancer agents (new compounds or new drug combinations); studies investigating individual differences in toxicity or responses (i.e., predictive biomarkers) are of particular interest.
Topic Editor Dr. Maria Vieito is on the Advisory Board for BMS and Speaker's Bureau for Novocure. Dr. Vieito has also received financial support from AstraZeneca, BeiGene, C4 Therapeutics, Novartis, Roche, Taiho Oncology and Thermo Fisher. Topic Editor Dr. Matteo Simonelli is on the Advisory Board for Servier, Incyte, GSK and BMS and is responsible for Data Safety Monitoring for Sanofy. The other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords:
Novel immunotherapeutic agents, Bispecific antibodies, ADCs, Bispecific ADCs, T-cell engager, Vaccination, CAR T-cell therapy, Immune-related adverse events, Early phase clinical trials, Trial design
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
Drug development in oncology is historically challenging, exhibiting a very high attrition rate, with low rates of approval for novel treatments when compared to other therapeutic areas. At present, along with the advent of novel targeted agents and immunotherapeutic strategies, designs, and aims of early-phase clinical trials in oncology have radically changed, switching from exploring safety to integrating more ambitious efficacy endpoints. Prognostic scoring systems specifically addressing outcomes of patients treated in early phase clinical trials testing novel immunotherapeutic agents are strongly needed, helping clinicians to identify who might actually benefit from trial recruitment. Last but not least, novel classes of immunotherapeutic strategies, such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy, and their combinations with immune-checkpoint inhibitors (and immunomodulatory antibodies against novel check-points), present with a new set of adverse events, requiring specific management and an adaptive trial design, for example accounting for late-onset toxicities and permitting interim dose decisions on the basis of partial toxicity information.
The goal of the present Research Topic is to acquire better knowledge and insight into the most recent advances in early-phase clinical trials assessing novel immunotherapeutic agents. Specifically, we aim to:
1. Investigate how to refine the trial design in order to improve efficiency in the drug development pathway.
2. Define patient selection at study enrolment, maximizing therapeutic intent (e.g.: optimizing prognostic scores based on clinical, pathological, and molecular variables).
3. Tackle the implementation of pharmacodynamics markers for novel immunotherapeutic anti-cancer agents
4. Gain expertise in the management of treatment-related adverse events emerging with the experimental use of next-generation immunotherapeutic agents such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy and their combinations with other immunomodulatory agents or standard anticancer (chemotherapy, radiotherapy, targeted therapy).
We welcome the submission of the following article types:
- Case Reports describing exceptional toxicities and their management when testing novel immunotherapeutic agents such as bispecific antibodies, T-cell engagers, cancer vaccines, chimeric antigen receptor (CAR) T-cell therapy, and their combinations with immune-checkpoint inhibitors (and immunomodulatory antibodies against novel check-points).
- Review Articles providing concise and precise updates on the latest progress made in the field of early-phase immunotherapeutic drug development; reviews are meant to identify gaps and controversies, and provide new perspectives and critical evaluation of current knowledge and methodology.
- Original Research Articles reporting clinical trials that involve early stages of drug development of novel immunotherapeutic anti-cancer agents (new compounds or new drug combinations); studies investigating individual differences in toxicity or responses (i.e., predictive biomarkers) are of particular interest.
Topic Editor Dr. Maria Vieito is on the Advisory Board for BMS and Speaker's Bureau for Novocure. Dr. Vieito has also received financial support from AstraZeneca, BeiGene, C4 Therapeutics, Novartis, Roche, Taiho Oncology and Thermo Fisher. Topic Editor Dr. Matteo Simonelli is on the Advisory Board for Servier, Incyte, GSK and BMS and is responsible for Data Safety Monitoring for Sanofy. The other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords:
Novel immunotherapeutic agents, Bispecific antibodies, ADCs, Bispecific ADCs, T-cell engager, Vaccination, CAR T-cell therapy, Immune-related adverse events, Early phase clinical trials, Trial design
Important Note:
All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.