Abstract 2613
Background
ICI and VEGFR-targeted therapies are the primary treatments for mRCC. Len plus Eve is currently approved based on improved progression-free survival (PFS) in pts with progressive disease after one prior VEGFR-targeted therapy. However, its efficacy beyond second-line, and after ICI, is not well defined.
Methods
We conducted a retrospective study of pts with mRCC who were treated with Len alone, or in combination with Eve, after at least 2 prior lines of therapy, including ICI and VEGFR-TKI. We report clinical benefit (CB), defined as partial response (PR) + stable disease (SD), PFS, overall survival (OS), and adverse events (AE).
Results
Between 11/2016 and 2/2019, we identified 40 pts with mRCC who were treated with Len +/- Eve. Median age was 59 years (range, 34-76); 62.5% were male; 52.5% had ECOG PS 1 and 35% had ECOG PS 2; 77.5% had clear cell histology; 85% had prior nephrectomy and 95% had metastatic disease in >/= 3 sites; 2.5% had IMDC favorable-risk, 87.5% intermediate-risk, and 10% poor-risk disease. The median number of prior lines of therapy was 4 (range, 2-10); 70% received Len+Eve and 62.5% were treated with Len +/- Eve as 5th-line or later. All pts had prior ICI exposure, primarily nivolumab monotherapy (70%), and 87.5% received >/= 2 prior VEGFR-TKIs. CB was achieved in 67.5% (30% PR + 37.5% SD). At a median follow up of 8.5 months (mo), median PFS was 4.2 mo (95% CI, 3.4-6.5), with a 6-mo PFS probability of 34% (95% CI, 21%-54%). Median OS was 10.8 mo (95% CI, 5.4-13.3), with a 1-year OS probability of 37% (95% CI, 21%-65%). Twenty-three pts (57.5%) have died, and of those only 4 received further therapies after Len +/- Eve. Dose reduction was required in 45% of pts, and the most common grade 3 or 4 AEs were proteinuria (17.5%), fatigue (10%), and diarrhea (10%). Treatment was discontinued in 4 pts (10%) because of toxicity.
Conclusions
Len alone and in combination with Eve demonstrated clinical benefit, with an overall response rate of 30%, and was well tolerated in heavily pretreated pts with mRCC after prior ICI and VEGFR-targeted therapies, supporting its use in this patient population.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
Z. Lim: Speaker Bureau / Expert testimony: Exelixis. M.T. Campbell: Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), non-branded educational programs: EMD Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), non-branded educational programs: Pfizer; Honoraria (self), Advisory / Consultancy: Genentech; Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Apricity Health; Research grant / Funding (self): Exelixis; Research grant / Funding (self): Janssen; Speaker Bureau / Expert testimony, non-branded educational programs: Bristol-Meyers Squibb; Speaker Bureau / Expert testimony, non-branded educational programs: Roche; Speaker Bureau / Expert testimony, non-branded educational programs: Merck. A.Y. Shah: Honoraria (self), Research grant / Funding (self): Eisai; Honoraria (self): Oncology Information Group; Honoraria (self): Roche; Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): EMD Serono. A. Zurita Saavedra: Speaker Bureau / Expert testimony: McKesson Specialty Health; Speaker Bureau / Expert testimony: Janssen-Cilag, S.A.DEC.V.; Advisory / Consultancy: Incyte; Advisory / Consultancy: Pfizer. E. Jonasch: Advisory / Consultancy, Research grant / Funding (self): Exelixis; Advisory / Consultancy, Research grant / Funding (self): Novartis; Research grant / Funding (self): Peloton; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Genentech; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Roche. N.M. Tannir: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Exelixis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Nektar; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Calithera Biosciences Inc.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai Medical Research; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ono Pharmaceutical; Advisory / Consultancy, Travel / Accommodation / Expenses: Oncorena; Research grant / Funding (self): Epizyme; Research grant / Funding (self): Mirati Therapeutics. All other authors have declared no conflicts of interest.
Resources from the same session
3047 - Health-related quality of life in Greek haematogical malignancies patients undergoing chemotherapy
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract
1121 - Experiences of endocrine therapy after breast cancer surgery
Presenter: Susanne Ahlstedt Karlsson
Session: Poster Display session 3
Resources:
Abstract
2305 - The effects of progressive muscle relaxation and mindfulness meditation on fatigue, coping styles, and quality of life in breast cancer patients receiving adjuvant paclitaxel regimen: An-assessor blinded, three-arm randomized controlled trial
Presenter: Zehra Gok Metin
Session: Poster Display session 3
Resources:
Abstract
4561 - Agreement between breast cancer patients and oncologists on the severity of patients’ symptoms and functions during a one-year follow-up after treatment.
Presenter: Randi Reidunsdatter
Session: Poster Display session 3
Resources:
Abstract
1768 - Taste Changes and Associated Factors in Patients Receiving Chemotherapy
Presenter: Gulcan Bagcivan
Session: Poster Display session 3
Resources:
Abstract
1830 - CART-19: a comparative between literature versus experience
Presenter: Cassandra Andersson Vila
Session: Poster Display session 3
Resources:
Abstract
4027 - Unplanned emergency department use by people receiving ambulatory anti-cancer agents with potential febrile neutropenia
Presenter: Meritxell Casanovas-Blanco
Session: Poster Display session 3
Resources:
Abstract
4754 - Examining the benefits of medical exercise during radiotherapy in patients after mastectomy
Presenter: Nikolina Dodlek
Session: Poster Display session 3
Resources:
Abstract
2510 - Assessment Quality of Life with Hand-Foot Syndrome Induced by Apatinib Combined with Anti-PD-1 Therapy in NSCLC
Presenter: Qi Jiang
Session: Poster Display session 3
Resources:
Abstract
2989 - Adverse effects of chemotherapy influence the patients’ quality of life : Analysis of implicated factors
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract