1693P - CaboPoint: Final results from a phase II study of cabozantinib after checkpoint inhibitor (CPI) combinations in patients with advanced renal cell carcinoma (aRCC)

Background

We report final data from CaboPoint, a prospective study of second-line (2L) cabozantinib in aRCC after first-line (1L) standard of care CPI-based therapy.

Methods

CaboPoint (NCT03945773) is a multicenter, open-label trial in adults with locally advanced, or metastatic clear cell RCC with progression on 1L CPI-based therapy. Patients (pts) started 2L cabozantinib at 60 mg/day after 1L nivolumab + ipilimumab (cohort A) and 1L CPI + VEGF-targeted therapy (cohort B). Primary endpoint: objective response rate (ORR) by independent review committee (IRC) in cohort A (per RECIST 1.1). Secondary endpoints: ORR by IRC in cohort B, ORR by investigator review (IR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.

Results

127 pts were included (cohort: A, 85; B, 42) and median follow-up was 19.3 months. Baseline characteristics were similar in cohorts A and B: mean age, 63.2 and 66.2 years; male, 74% and 79%; IMDC risk, favourable, 4% and 18%, intermediate, 47% and 39%, poor, 12% and 13%, unknown, 38% and 31%. Efficacy results are in the table. In cohorts A and B: common (>10% of pts) grade 3/4 treatment-emergent adverse events (TEAEs) were hypertension (38% and 21%) and diarrhoea (12% and 10%); TEAEs led to treatment interruption in 88% and 76% of pts and discontinuation in 19% and 19%; treatment-related serious TEAEs occurred in 29% and 17%. Table: 1693P

95% CIs in brackets. ^aExcludes pts with no baseline target lesions.^bPts with missing data considered to be non-responders.^cTested against a 10% threshold.CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease

Conclusions

2L cabozantinib was effective in aRCC pts in the post-CPI combination setting and had no new safety signals.

Clinical trial identification

NCT03945773.

Editorial acknowledgement

Medical writing support was provided by Jo Gordon and David Gothard, of Oxford PharmaGenesis, Oxford, UK which was sponsored by Ipsen.

Legal entity responsible for the study

Ipsen.

Funding

Ipsen.

Disclosure

L. Albiges: Financial Interests, Institutional, Other, Consulting: Astellas, BMS, Eisai, Ipsen, Janssen, MSD, Novartis, Pfizer, Roche, Merck, Amgen; Financial Interests, Personal, Other, Honoraria: Novartis; Non-Financial Interests, Principal Investigator, Clinical trial steering committee: Pfizer, BMS, Aveo, AstraZeneca, MSD; Non-Financial Interests, Principal Investigator: Ipsen; Non-Financial Interests, Other, Clinical trial steering committee: Roche, Exelixis; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Other, Medical Steering Committee: Kidney Cancer Association; Non-Financial Interests, Other, Member of the Renal Cell Carcinoma Guidelines Panel: European Association of Urology (EAU). T.B. Powles: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Exelixis, Incyte, Ipsen, Merck, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai, Roche, MSD; Financial Interests, Personal, Other, Travel/Accommodation/Expenses: Roche, Pfizer, MSD, AstraZeneca, Ipsen; Financial Interests, Personal, Other, Sponsorship for Uromigos Podcast: Mashup Ltd; Financial Interests, Institutional, Other, honoraria: Gilead; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Ipsen, Merck, MSD, Seattle Genetics, Novartis, Pfizer, Merck Serono, Astellas, Johnson & Johnson, Eisai; Financial Interests, Institutional, Other, Honoraria: Gilead. A. Sharma: Financial Interests, Personal, Advisory Role: MSD Oncology, BMS; Financial Interests, Personal, Speaker’s Bureau: MSD Oncology, EUSA Pharma, Merck Serono, Eisai/MSD, BMS GmbH & Co. KG, Janssen Oncology, Pfizer/EMD Serono, Ipsen; Financial Interests, Personal, Other: MSD, Eusa Pharma, Ipsen. B. Venugopal: Financial Interests, Personal, Advisory Role: Pfizer/EMD Serono, MSD Oncology, BMS, Eisai; Financial Interests, Personal, Speaker’s Bureau: MSD Oncology, Pfizer, Eisai, Janssen Oncology, Ipsen, BMS Foundation/Janssen; Financial Interests, Personal, Other, Expenses: Ipsen, Eusa Pharma, Merck Serono; Financial Interests, Personal, Other: Pfizer, BMS, Eusa Pharma, Eisai, Ipsen, Merck, MSD Oncology; Financial Interests, Institutional, Research Funding: Pfizer/EMD Serono, Calithera Biosciences, MSD Oncology, Ipsen. J. Bedke: Financial Interests, Personal, Advisory Role: BMS, Eisai, Eusa Pharma, Ipsen, MSD Oncology, Roche, Pfizer, Merck KGaA; Financial Interests, Personal, Speaker’s Bureau: MSD Oncology, BMS, Merck KGaA, Pfizer, Ipsen, Astellas Pharma, Apogepha; Financial Interests, Institutional, Research Funding: BMS, Astellas Pharma, Ipsen, MSD Oncology, Novartis, Roche, Exelixis, Pfizer, Seagen. G. Gravis: Financial Interests, Institutional, Invited Speaker: AAA, Amgen, Astellas, BMS, Janssen, MSD, Pfizer, Ipsen, AstraZeneca, alliance Merck Pfizer, Bayer, Eisai; Financial Interests, Institutional, Advisory Board: Alliance Merck-Pfizer, BMS, Janssen, Pfizer, Ipsen, Bayer, Eisai; Financial Interests, Institutional, Funding: Janssen; Financial Interests, Institutional, Coordinating PI: BMS; Non-Financial Interests, Principal Investigator: Ipsen, BMS, Merck. B.C. Özdemir: Financial Interests, Institutional, Advisory Board: Roche, Ipsen, MSD, Pfizer, Sanofi; Financial Interests, Institutional, Invited Speaker: Merck, Novartis; Financial Interests, Institutional, Other, Reduction for registration fee for ASCO Gu: Janssen; Financial Interests, Institutional, Local PI: Parexel, Seattle Genetics, MSD. M.J. Schnabel: Financial Interests, Personal, Stocks or ownership: BMS; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, Apogepha, Bayer, BMS, Ipsen, Janssen, Merck, Medac, MSD, Novartis, Pfizer. P. Dutailly: Financial Interests, Personal, Full or part-time Employment: Ipsen. B. Qvick: Financial Interests, Personal, Full or part-time Employment: Ipsen; Financial Interests, Personal, Stocks or ownership: Ipsen. V. Perrot: Financial Interests, Personal, Full or part-time Employment: Ipsen; Financial Interests, Personal, Stocks or ownership: Ipsen. V. Gruenwald: Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, BMS, Eisai, Ipsen, Janssen-Cilag, MSD, Merck Serono, Novartis, Pfizer, Gilead; Financial Interests, Personal, Advisory Board: Apogepha, BMS, Debiopharm, Eisai, MSD, Merck Serono, Oncorena, PCI Biotech, Pfizer, Roche, Cureteq, Synthekine; Financial Interests, Personal, Stocks/Shares: BMS, MSD, AstraZeneca, Bicycle; Financial Interests, Institutional, Steering Committee Member: BMS, Novartis; Financial Interests, Institutional, Research Grant: Ipsen, MSD, Pfizer, BMS; Financial Interests, Personal and Institutional, Steering Committee Member: Eisai, Ipsen; Non-Financial Interests, Member: ASCO, German medical Oncology and Hematology Society; Non-Financial Interests, Advisory Role: German Cancer Society; Non-Financial Interests, Leadership Role: Working Group medical oncology; Other, Travel support to ESMO 2022: Pfizer; Other, Travel support for meeting: Merck Serono; Other, Travel Support ASCO GU 2024: Ipsen; Other, Travel Support: Janssen Cilag. All other authors have declared no conflicts of interest.