(Pancreatic Cancer) Imfinzi + Tremelimumab Efficacy?

(Pancreatic Cancer) Imfinzi + Tremelimumab Efficacy?

(Pancreatic Cancer) Imfinzi + Tremelimumab Efficacy?

• September 11, 2019
• Reading time 2 minutes

On July 18, 2019, Eileen M. O'Reilly published in JAMA Oncology: "Efficacy and safety verification of anti-PD-L1 antibody Imfinzi ± anti-CTLA-4 antibody Tremelimumab in metastatic pancreatic ductal adenocarcinoma patients in Phase 2 clinical trial."

This Phase 2 clinical trial compared metastatic pancreatic ductal adenocarcinoma patients with primary endpoint objective response rate and secondary endpoints including disease control rate, progression-free survival, and overall survival.

Tremelimumab combination group (4-week cycle, Imfinzi 1500mg + Tremelimumab 75mg, then Imfinzi 1500mg monotherapy after four cycles, N=32 patients).

Imfinzi group (4-week cycle, Imfinzi 1500mg, N=33 patients).

This trial background was because 90% of pancreatic cancer patients have pancreatic ductal adenocarcinoma with approximately 8% five-year survival rate with poor prognosis. Recent years showed immune checkpoint inhibitors beneficial for multiple cancer types, with hopes for effectiveness in pancreatic ductal adenocarcinoma. To confirm efficacy of Imfinzi ± Tremelimumab in metastatic pancreatic ductal adenocarcinoma, this trial was initiated.

Patient characteristics (65 patients):

Median age: Tremelimumab combination 60.0 years (37-81); Imfinzi 62.0 years (40-78).

Gender: Tremelimumab combination 46.9% male; Imfinzi 57.6% male.

Race: Tremelimumab combination 53.1% Caucasian, 46.9% Asian; Imfinzi 66.7% Caucasian, 30.3% Asian.

Daily functional status: Tremelimumab combination ECOG 0: 43.8%, ECOG 1: 53.1%; Imfinzi ECOG 0: 33.3%, ECOG 1: 63.6%.

PD-L1 expression TC25% or higher: Tremelimumab combination 12.5%; Imfinzi 12.1%.

Median previous treatment regimens: Both groups one regimen.

Previous treatment drugs: Tremelimumab combination 5FU-based 56.3%, gemcitabine-based 37.5%, other 6.3%; Imfinzi 5FU-based 60.6%, gemcitabine-based 33.3%, other 6.1%.

Trial results showed primary endpoint objective response rates: Tremelimumab combination 3.1% / Imfinzi 0%. Both fell short of target 10% response rate.

Secondary endpoints 3-month disease control rate: Tremelimumab combination 9.4% / Imfinzi 6.1%. Median progression-free survival: Tremelimumab combination 1.5 months / Imfinzi 1.5 months. 6-month progression-free survival: Tremelimumab combination 9.4% / Imfinzi 3.6%.

Median overall survival: Tremelimumab 3.1 months / Imfinzi 3.6 months. 6-month overall survival: Tremelimumab combination 36.2% / Imfinzi 34.9%. 12-month overall survival: Tremelimumab combination 8.8% / Imfinzi 6.3%.

Safety showed adverse event rates: Tremelimumab combination 34% (N=11/32) / Imfinzi 31% (N=10/32). Grade 3+ adverse events: Tremelimumab combination 22% (N=7/32) / Imfinzi 6% (N=2/32).

Adverse events above 5% included: Fatigue Tremelimumab combination 13% / Imfinzi 9%. Diarrhea Tremelimumab combination 13% / Imfinzi 6%. Itching Tremelimumab combination 3% / Imfinzi 6%. Hypothyroidism Tremelimumab combination 9% / Imfinzi 6%.

Based on Phase 2 trial results, Eileen M. O'Reilly concluded: Metastatic pancreatic ductal adenocarcinoma patients treated with anti-PD-L1 antibody Imfinzi ± anti-CTLA-4 antibody Tremelimumab show manageable adverse events, but did not achieve target primary endpoint objective response rate.

Note: The clinical trial data and medical information translated by "Medical Assistant" from overseas trials are not intended to promote participation in clinical trials or use of new drugs. Translation materials are for reference only, not as medication guidelines. Please consult healthcare professionals and refer to original content for accuracy.

Source: Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma(JAMA Oncol. 2019 Jul 18. doi: 10.1001/jamaoncol.2019.1588.)

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