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Poster session 16

1246P - Multicenter phase Ib/II study of second-line varlitinib and paclitaxel in patients with EGFR/HER2 co-expressing advanced gastric cancer (K-MASTER-13)

Date

10 Sep 2022

Session

Poster session 16

Topics

Tumour Site

Gastric Cancer

Presenters

Minkyu Jung

Citation

Annals of Oncology (2022) 33 (suppl_7): S555-S580. 10.1016/annonc/annonc1065

Authors

M. Jung1, Y.H. Kim2, H.C. Jeung3, D.Y. Zang4, W.K. Bae5, D. Koo6, H. Kim7, H.S. Kim8, C. Lee9, H.C. Chung10, S.Y. Rha11

Author affiliations

  • 1 Divison Of Medical Oncology, Department Of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, 03722 - Seoul/KR
  • 2 Department Of Hemato-oncology, Korea University Anam Hospital, 02841 - Seoul/KR
  • 3 Department Of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 06273 - Seoul/KR
  • 4 Internal Medicine Department, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 5 Oncology Department, Chonnam National University Hwasun Hospital, 519-763 - Hwasun/KR
  • 6 Division Of Hematology/oncology, Department Of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 03181 - Seoul/KR
  • 7 Pathology, Yonsei Cancer Center Yonsei University, 120-752 - Seoul/KR
  • 8 Divison Of Medical Oncology, Department Of Internal Medicine, Yonsei University College of Medicine, 120-752 - Seoul/KR
  • 9 Division Of Medical Oncology, Yonsei Cancer Center Yonsei University, 120-752 - Seoul/KR
  • 10 Medical Oncology Dept, Yonsei University, 03722 - Seoul/KR
  • 11 Medical Oncology Department, Yonsei University, 03722 - Seoul/KR

Resources

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Abstract 1246P

Background

Varlitinib is a small-molecule inhibitor of the tyrosine kinases EGFR, HER2, and HER4. We present a phase Ib/II study to evaluate the safety and efficacy of varlitinib in combination with weekly paclitaxel in EGFR/HER2 co-expressing advanced gastric cancer (AGC) patients. (KCT0003583).

Methods

AGC patients who had failed 1st line fluoropyrimidine-containing chemotherapy, with evidence of both EGFR and HER2 overexpression by IHC (≥1+), were enrolled. Varlitinib [Dose 1: 300 mg BID, Dose -1: 300mg intermittent dose] and paclitaxel (80 mg/m2 D1,8,15) were investigated every 4 weeks. After determining the DLT and RP2D in phase Ib, phase II part was conducted to evaluate the anti-tumor activity with a primary endpoint of PFS.

Results

In the phase Ib study, 9 subjects were enrolled at the dose 1 level of varlitinib 300mg, of which 6 patients were evaluable for safety per protocol. Among the 6 evaluable patients, there was 1 DLT of Grade 4 AST/ALT elevation. The RP2D was varlitinib 300mg once daily combined with paclitaxel (80mg/m2 on days 1, 8, and 15). The median follow-up duration of 9.3 months [95% confidence interval (CI), 6.1-12.5]. Among 27 patients treated with RP2D including 5 subjects from Phase Ib, median PFS and OS were 4.1 (95% CI, 2.4-4.9 months) and 7.9 months (95% CI, 3.3-12.5 months), respectively. Among 16 patients with measurable disease and administered with RP2D, confirmed response and disease control was observed in 5 patients (ORR=31.3%) and 14 patients (DCR=87.5%), respectively. No definite association between EGFR or HER2 high expression and the efficacy of varlitinib and paclitaxel could be determined. Most common any grade of adverse events (AEs) were neutropenia (51.8% and 22.2% of Grade 3), diarrhea (27.3%), and AST/ALT elevation (22.2% and 11.1% of Grade 3). No treatment related death or unexpected AEs resulting in treatment cessation were observed with the RP2D.

Conclusions

Varlitinib combined with paclitaxel revealed manageable toxicities and antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy. Updated outcomes for ongoing patients and biomarker analysis will be presented.

Clinical trial identification

KCT0003583.

Editorial acknowledgement

Varlitinib was supported by ASLAN Pharmaceuticals.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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