Phase 2 studies of multiple peptides cocktail vaccine for treatment-resistant cervical and ovarian cancer.

Authors

Satoshi Takeuchi

Satoshi Takeuchi

Iwate Medical University, Morioka Iwate, Japan

Satoshi Takeuchi , Tadahiro Shoji , Masahiro Kagabu , Tatsuya Honda , Atsumi Kojima , Yukari Nitta , Toru Sugiyama , Yusuke Nakamura

Organizations

Iwate Medical University, Morioka Iwate, Japan, Iwate Medical University School of Medicine, Morioka, Japan, Iwate Medical University, Morioka, Japan, Gynecologic Oncology, Shikoku Cancer Center, Matsuyama, Japan, Iwate Medical University School of Medicine Gynecology, Morioka, Japan, Iwate Medical University, Morioka-shi, Japan, The University of Chicago, Chicago, IL

Research Funding

Other

Background: We have conducted phase 2 studies of peptides vaccine (PV) immunotherapy for cervical (CC) and ovarian cancer (OC) using human leukocyte antigen (HLA)-restricted tumor specific epitope peptide and VEGF receptor1 (VEGFR1) and 2. Institutional review board had approved these studies. Methods: All patients (pts) with heavily treated and with HLA-A2402 or A0201 within PS2 were enrolled. Written-informed consent had obtained. Enrollment finished on October 20,2014. PV cocktail were as follows: FOXM1, MELK, HJURP,HIG2,VEGFR1 and VEGFR2 for OC, FOXM1, MELK, HJURP,URLC10 and HIG2 for CC. Each peptide (GMP grade) was mixed at a dose of 1mg with 1ml of adjuvant, MONTANIDE,ISA51. Vaccination schedule included 12 subcutaneous weekly injections. Thereafter, additional administrations (adms) were performed. CTL was analyzed by ELISpot assay. Clinical responses were evaluated every three months by RECIST v 1.1 and additional immune-responsive (ir-) RECIST Results: Twenty one pts of CC and 46 pts of OC were enrolled. PV was generally well tolerated with no major adverse events, and most of the patients developed specific CTL responses until 8 adms. Two patients showed complete response by RECIST. Median overall survival(mOS) of CC and OV was 15.4 months(m)and 8.8 m,respectively. No significant survival benefits were seen among HLA type and histology subtypes, but c-reactive protein levels (lower than 2.0 mg/dl) at base line in OC and dermatological hypersensitivity (DTH) during adms in CC and OC was strongly related their OS. Lower CRP group showed longer median OS (mOS = 19.0m vs. 3.0m, logrank p = 0.0016) in OC. As for DTH, negative versus positive patients, the mOS was 3.3 m vs. 21.2m, logrank p = 0.065, in CC, and it was 1.4 m vs. 17.7 m, logrank p < 0.0001, in OC. Conclusions: These findings suggest that this PV immunotherapy was safe and effective even for incurable patients and they would be applicable for maintenance therapy for cervical and ovarian cancer. Clinical trial information: UMIN000003860,3862,3902,3903.

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

UMIN000003860,3862,3902,3903

Citation

J Clin Oncol 33, 2015 (suppl; abstr 5567)

DOI

10.1200/jco.2015.33.15_suppl.5567

Abstract #

5567

Poster Bd #

125

Abstract Disclosures