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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4553 - Responder analysis based on patient-reported outcomes (PROs) and clinical endpoints (CEPs) in patients (pts) with metastatic Merkel cell carcinoma (mMCC) treated with avelumab

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Sandra D'Angelo

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

S.P. D'Angelo1, F. Fofana2, M. Schlichting3, M. Henry-Szatkowski4, M. Hennessy5, M. Bharmal6

Author affiliations

  • 1 Medical Oncology, Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College, 10065 - New York/US
  • 2 Patient-centered Outcomes, Mapi Group, Leiden/NL
  • 3 Biostatistics, Merck KGaA, Darmstadt/DE
  • 4 Patient-centered Outcomes, Mapi Group, Lyon/FR
  • 5 Medical Oncology, EMD Serono, Billerica/US
  • 6 Global Evidence & Value Development, Merck KGaA, Darmstadt/DE
More

Resources

Abstract 4553

Background

To better understand the impact of the anti–PD-L1 antibody avelumab, clinical outcomes and PROs in chemotherapy-refractory pts with mMCC enrolled in a single-arm, international phase 2 trial (NCT02155647) were analysed. Here we explore the proportion of pts categorised as responders based on these outcome measures.

Methods

PROs were assessed at baseline (BL), at week 7, thereafter Q6W until disease progression, and at end of treatment using EQ-5D, a generic health-related quality of life (HRQoL) tool, and FACT-M, a cancer-specific HRQoL tool. Pts were categorised as meaningfully improved/stable or as meaningfully worsened. HRQoL deterioration-free survival (QFS) was defined as the time from BL to either a meaningful worsening from BL with no further improvement in HRQoL or death. QFS rates of PRO endpoints were computed at specific time points. Responders based on PRO meaningfully improved/stable and QFS analyses were described along with the best overall response (BOR) and progression-free survival (PFS) analyses assessed by IERC per RECIST v1.1.

Results

As of Sept 26, 2017, 88 pts had been followed for a minimum of 24 months (mo; median, 29.2 [range, 24.8-38.1]). The table presents responders based on PROs and CEPs at 6, 12, 18, and 24 mo. In addition, PRO-based, 2-year rates of improved/stable endpoints tended to be higher than the BOR rate of 33%, ranging from 41% for FACT-M physical well-being to 58% for FACT-M melanoma surgery scale.Table: 1282P

6 mo12 mo18 mo24 mo
CEPs
PFS rate, %40292926
PRO endpoints
QFS rate, %EQ-5D VAS52524938
FACT-M total45403632
FACT-M physical well-being44373333
FACT-M social/family well-being40403126
FACT-M emotional well-being45403333
FACT-M functional well-being41343127
FACT-M melanoma subscale53423939
FACT-M melanoma surgery scale46433838
FACT-G total41393531

Conclusions

The findings show similarity in the proportion of responders based on clinical and PRO endpoints, reiterating the potential association of both outcome measures in this mMCC population. This confirms the interest in using PROs in trials to contribute to the interpretation of objective CEPs.

Clinical trial identification

NCT02155647.

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.

Funding

This trial was sponsored by Merck KGaA, Darmstadt, Germany and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany.

Editorial Acknowledgement

Medical writing support was provided by ClinicalThinking Inc., Hamilton, NJ, USA.

Disclosure

S.P. D'Angelo: Financial interest from EMD Serono, Pfizer, and Nektar. F. Fofana: Employee: Mapi Group. M. Schlichting, M. Bharmal: Employee: Merck KGaA. M. Henry-Szatkowski: Employee: Mapi Group; Paid consultant: Merck KGaA. M. Hennessy: Employee, Financial interest: EMD Serono.

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