Editing Clinical Trials (section)

== What Are the Latest Immunotherapy Results? ==

=== Pembrolizumab Plus Chemotherapy — FDA Approved September 2024 ===

The KEYNOTE-483 trial led to FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma on September 17, 2024.<ref>[https://www.mesotheliomalawyercenter.org/mesothelioma/prognosis/ Mesothelioma Prognosis], Mesothelioma Lawyer Center</ref>

'''Trial Results:'''
* '''Median overall survival:''' 16.9 months versus 14.1 months with chemotherapy alone
* '''Hazard ratio:''' 0.79 (95% CI: 0.63-0.99; p=0.0209)
* '''Confirmed objective response rate:''' 52% versus 29%
* '''Median duration of response:''' 6.9 versus 6.8 months
* '''Regimen:''' Pembrolizumab with pemetrexed and platinum chemotherapy

'''January 2026 Update:''' FDA approved Keytruda QLEX (subcutaneous pembrolizumab) on January 11, 2026, offering a 1-minute injection every 3 weeks as an alternative to IV infusion for all 38 pembrolizumab indications including mesothelioma.

=== Nivolumab Plus Ipilimumab — CheckMate 743 Long-term Data ===

CheckMate 743 remains the only Phase 3 trial demonstrating survival improvement sustained over 3 years with first-line immunotherapy in unresectable malignant pleural mesothelioma.<ref>[https://mesothelioma.net/treatment-for-mesothelioma/ Mesothelioma Treatment Options], Mesothelioma.net</ref>

'''Three-Year Follow-up Results:'''
* '''Three-year overall survival:''' 23.2% versus 15.4% with chemotherapy
* '''Sustained benefit:''' Observed regardless of histology
* '''Duration of response:''' Longer with dual immunotherapy at 3 years
* '''Safety:''' Consistent profile with no new signals at long-term follow-up

{| style="width:90%; margin:1.5em auto; background:#f8f9fa; border-left:4px solid #1a5276; border-radius:0 4px 4px 0;"
|-
| style="padding:20px 25px 15px; font-style:italic; font-size:1.05em; line-height:1.6;" | "Clinical trials represent the cutting edge of mesothelioma treatment. We encourage every patient to explore trial options because tomorrow's standard treatments are available today through these programs. The survival improvements we're seeing with newer therapies are remarkable."
|-
| style="padding:5px 25px 20px; text-align:right;" | '''— Paul Danziger,''' Founding Partner, Danziger & De Llano
|}

=== BNT327/PM8002 — Exceptional Peritoneal Mesothelioma Results ===

This PD-L1/VEGF-A bispecific antibody demonstrated remarkable activity at ASCO 2025, particularly in peritoneal mesothelioma.<ref>[https://mesotheliomaattorney.com/mesothelioma/types/peritoneal/ Peritoneal Mesothelioma], MesotheliomaAttorney.com</ref>

'''Phase 2 Trial Results (31 patients with unresectable mesothelioma):'''
* '''Confirmed overall response rate:''' 51.6%
* '''Peritoneal mesothelioma cohort (8 patients):''' 75% ORR, 100% disease control rate
* '''Median exposure:''' 16.0 months (95% CI 8.1-19.5)
* '''Median follow-up:''' 19.3 months
* '''Safety:''' 93.5% experienced grade 3/4 adverse events; no treatment-related deaths

Phase 3 trial planning is underway (NCT07133750 registered July 2025).

=== UV1 Vaccine Plus Checkpoint Inhibitors ===

The NIPU trial (Phase II, NCT04300244) demonstrated statistically significant survival improvement when UV1 telomerase vaccine was added to nivolumab plus ipilimumab.<ref>[https://www.mesotheliomalawyercenter.org/blog/cancer-vaccine-presents-promising-new-treatment-for-mesothelioma/ Cancer Vaccine for Mesothelioma], Mesothelioma Lawyer Center</ref>

'''Results (118 patients randomized):'''
* '''Median overall survival:''' 15.4 months with UV1 versus 11.1 months without—statistically significant
* '''Median progression-free survival:''' 4.2 months versus 2.9 months
* '''Objective response rate:''' 31% versus 16%
* '''Safety:''' Comparable adverse event rates between groups
* '''Regulatory Status:''' FDA Fast Track Designation granted February 2024