610P - Analyzing the clinical benefit of the evidence presented at these congresses and utilizing a standardized scale to quantify it will significantly enhance our understanding of the studies showcased, allowing for more objective evaluation and interpretation

Background

The ESMO-MCBS is a valuable tool for the systematic evaluation of clinical benefit of trials. We investigated the applicability of the MCBS in phase 3 trials presented at a major international conference.

Methods

We assessed phase 3 metastatic solid tumor trials presented at ASCO22 which completed recruitment. We included data from the abstract and/or prior and/or subsequent full publication (until March 24^th, 2023). MCBS v1.1 evaluation form 2A, 2B, 2C and 3 were used. Preliminary scores were based on overall survival (OS), progression-free survival, and overall response rate, and adjusted according to the pre-specified criteria of the respective evaluation form to reach a final score. Abstracts pertaining to the same study were graded only once and those with subgroups were ranked using the subgroup with the highest score. Grading was performed by three independent reviewers. Discrepancies were resolved through consensus discussion. According to the MCBS, trials scoring ≥ 4 were considered to have meaningful clinical benefit.

Results

Fifty-five phase 3 trials were evaluated, of which 5 could not be scored due to an ungradable endpoint, insufficient or immature data. Of the remaining 50 trials, 9 could not be graded due to statistically non-significant results. The remaining 41 trials were scored based on previous (n=10), subsequent publication (n=14), both (n=1) or abstract only (n=16). Thirteen preliminary scores were adjusted. A meaningful clinical benefit was seen in 21 of 41 trials (51%). Table: 610P

Conclusions

Overall, half of the phase 3 trials presented at ASCO22 showed a meaningful clinical benefit using the MCBS. A substantial number of trials could not get a score due to statistically non-significant results; it may be helpful to include these in a modified scale to give a more accurate picture of the clinical value these trials.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

E. Segelov: Non-Financial Interests, Personal, Member: ESMO-MCBS Working Group. All other authors have declared no conflicts of interest.