Evorpacept Combinations in Advanced Solid Tumors: Phase I Results

Phase I Trial Results

• November 29, 2021

On November 15, 2021, researchers led by Nehal J Lakhani published Phase I trial results in The Lancet, evaluating evorpacept (CD40 receptor agonist) combined with anti-PD-1 or anti-HER2 monoclonal antibodies in previously untreated advanced solid tumors unsuitable for standard therapy.

Trial Design

Patient Population: Previously untreated advanced solid tumors ineligible for standard therapy (n=110)

Treatment Arms:

• Evorpacept monotherapy 30 mg/kg (n=28)
• Evorpacept 0.3-10 mg/kg + Tislelizumab 200 mg (n=52)
• Evorpacept 0.3-10 mg/kg + Trastuzumab 6 mg/kg (n=30)

Primary Endpoints: Maximum tolerated dose, safety

Safety Results

Dose-Limiting Toxicities:

• Evorpacept alone: 7% (neutropenia, thrombocytopenia)
• Grade 3 thrombocytopenia: 4-7% across cohorts
• Grade 3 neutropenia: 7% (trastuzumab cohort)

Efficacy Results

Objective Response Rates:

• Squamous cell carcinoma (anti-PD-1): 20%
• Non-small cell lung cancer (anti-PD-1): 5%
• Gastric cancer (anti-HER2): 21.1%

Clinical Conclusions

Evorpacept combined with anti-PD-1 or anti-HER2 antibodies demonstrates acceptable safety profile in previously untreated advanced solid tumors.

Data Source

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00584-2/fulltext

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

Figure 1

Figure 2

Figure 3

Figure 4