(Gynecologic Cancers) Imfinzi + Lynparza + Cediranib Efficacy?

(Gynecologic Cancers) Imfinzi + Lynparza + Cediranib Efficacy?

(Gynecologic Cancers) Imfinzi + Lynparza + Cediranib Efficacy?

• August 20, 2019
• Reading time 2 minutes

On July 25, 2019, Alexandra S. Zimmer published in the Journal for ImmunoTherapy of Cancer: "Efficacy and safety verification of anti-PD-L1 antibody Imfinzi (durvalumab) + PARP inhibitor Lynparza (olaparib) + VEGFR-1/2/3 inhibitor Cediranib (AZD2171) in recurrent gynecologic cancer patients in Phase 1 clinical trial."

The Phase 1 clinical trial evaluated recurrent gynecologic cancer patients including ovarian cancer, endometrial cancer, and triple-negative breast cancer (N=9 patients) with 4-week cycles: Imfinzi 1500mg + Lynparza 300mg twice daily + weekly 1-5 days dosing + Cediranib 15-20mg. Primary endpoint was objective response rate, with Phase 2 recommended dose evaluation.

This trial background was based on previous clinical trials showing PARP inhibitor Lynparza + VEGFR-1/2/3 inhibitor Cediranib had higher anti-tumor efficacy compared to Lynparza alone in treatment-resistant recurrent ovarian cancer patients. Additionally, immune checkpoint inhibitors show good treatment outcomes across cancer types, but gynecologic cancer treatment outcomes have room for improvement. Based on this, this trial combined anti-PD-L1 antibody + PARP inhibitor + VEGFR-1/2/3 inhibitor.

Trial subject data:

Median age: 59 years (44-73 years)

BRCA Gene Mutation Status

Mutation: 1 patient

Wild-type: 7 patients

Unknown: 1 patient

Daily Functional Status

ECOG 0: 3 patients

ECOG 1: 6 patients

ECOG 3: 0 patients

Median Previous Treatment Regimens

2 regimens

Previous Treatment Drugs

PARP inhibitors: 0 patients

Avastin: 2 patients

Cancer Types

Ovarian cancer: 7 patients

Endometrial cancer: 1 patient

Triple-negative breast cancer: 1 patient

Based on above, trial results showed Grade 3-4 adverse events: hypertension 1 patient, anemia 1 patient, lymphocyte reduction 3 patients. No patients experienced dose-limiting toxicity. Primary Phase 2 recommended dose: 4-week cycle, Imfinzi 1500mg + Lynparza 300mg twice daily + Cediranib 20mg days 1-5 weekly. Another primary endpoint objective response rate was 44%, including 4 with partial response, 3 with stable disease, and clinical benefit rate 67%.

Based on Phase 1 trial results, Alexandra S. Zimmer concluded: Recurrent gynecologic cancer patients treated with anti-PD-L1 antibody Imfinzi + PARP inhibitor Lynparza + VEGFR-1/2/3 inhibitor Cediranib showed good anti-tumor efficacy with manageable adverse events. Proceeding to Phase 2 clinical trial to continue efficacy verification.

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: A phase I study of the PD-L1 inhibitor, durvalumab, in combination with a PARP inhibitor, olaparib, and a VEGFR1–3 inhibitor, cediranib, in recurrent women's cancers with biomarker analyses(J Immunother Cancer. 2019 Jul 25;7(1):197. doi: 10.1186/s40425-019-0680-3.)

#OvarianCancer #EndometrialCancer #BreastCancer #TripleNegativeBreastCancer

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