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Poster Discussion 2 – Immunotherapy of cancer

2521 - Safety and Efficacy of the Oral CXCR4 Inhibitor X4P-001 + Axitinib in Advanced Renal Cell Carcinoma Patients: An Analysis of Subgroup Responses by Prior Treatment

Date

30 Sep 2019

Session

Poster Discussion 2 – Immunotherapy of cancer

Presenters

David McDermott

Citation

Annals of Oncology (2019) 30 (suppl_5): v475-v532. 10.1093/annonc/mdz253

Authors

D.F. McDermott1, U. Vaishampayan2, M. Matrana3, S.Y. Rha4, A. Zurita Saavedra5, T. Ho6, B. Keam7, J. Lee8, R. Joseph9, S. Ali10, W. Stadler11, N.B. Haas12, S. Sundararajan13, S.H. Park14, R. Mowat15, J. Picus16, A.Z. Dudek17, Y. Zakharia18, L. Gan19, M.B. Atkins20

Author affiliations

  • 1 Hematology And Oncology, Beth Israel Deaconess Med. Center, 2215 - Boston/US
  • 2 Oncology, Barbara Ann Karmanos Cancer Institute, 48201 - Detroit/US
  • 3 Medical Oncology, Ochsner Cancer Institute, 70121 - New Orleans/US
  • 4 Internal Medicine, Yonsei University, 03722 - Seoul/KR
  • 5 Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 6 Medical Oncology, Mayo Clinic, 85054 - Phoenix/US
  • 7 Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 8 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 9 Oncology, Mayo Clinic, 32224 - Jacksonville/US
  • 10 Hematology And Medical Oncology, Franciscan St. Francis Health, 46237 - Indianapolis/US
  • 11 Hematology And Oncology, University of Chicago, 60637 - Chicago/US
  • 12 Hematology Oncology, University of Pennsylvania/Abramson Cancer Center, 19104 - Philadelphia/US
  • 13 Medicine, University of Arizona Cancer Center, 85724 - Tucson/US
  • 14 Division Of Hematology/oncology, Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 15 Oncology, Toledo Clinic Cancer Center, 43623 - Toledo/US
  • 16 Oncology, Washington University School of Medicine, 63110 - St. Louis/US
  • 17 Oncology, University of Minnesota, 55455 - Minneapolis/US
  • 18 Hem Onc, University of Iowa, 52242 - Iowa City/US
  • 19 Research And Development, X4 Pharmaceuticals, 02139 - Cambridge/US
  • 20 Oncology, Lombardi Cancer Center Georgetown University, 20007 - Washington/US

Resources

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Abstract 2521

Background

The CXCR4 chemokine receptor modulates immunosuppressive cell trafficking that can inhibit antitumor immune responses. X4P-001 is a selective, oral CXCR4 antagonist currently in clinical development as a novel therapy for solid tumors, including renal cell carcinoma (RCC). In xenograft models, X4P-001 in combination with axitinib, a VEGF receptor tyrosine kinase inhibitor (TKI), reduced myeloid-derived suppressor cell infiltration and proangiogenic signals and demonstrated greater than additive antitumor activity.

Methods

Here we report combined Phase I/II study results for 65 patients (Pts) with advanced RCC treated with 400 mg oral X4P-001 (200 mg BID or 400 mg QD) + 5 mg oral BID axitinib. All Pts had failed at least 1 prior treatment with a TKI, immuno-oncology (IO) agent, or other systemic therapy (2+, n = 49 Pts, 75%; 3+, n = 31, 48%) and had an ECOG performance status of ≤ 2.

Results

The median age was 64 years (range 42-87), and the median treatment duration was 25 weeks (range 1-148). Of the 65 Pts, 12 (18%) remain on combination therapy. The objective response rate (ORR) among the 62 clinically evaluable Pts was 29% (1 complete response; 17 partial responses) and the interim median progression-free survival (mPFS) was 7.4 months. The ORR for Pts receiving immediate prior TKI therapy was 18% (n = 34) and mPFS was 7.4 months. The ORR for Pts receiving immediate prior IO therapy was 61% (n = 18) and mPFS was 11.6 months. Thirteen Pts (20%) were discontinued from the study due to adverse events (AEs) regardless of attribution. The most common (> 20%) treatment-related (TR)AEs of any grade were diarrhea (35 Pts, 54%), decreased appetite (29 Pts, 45%), fatigue (28 Pts, 43%), hypertension (25 Pts, 38%), nausea (17 Pts, 28%), and dysphonia (14 Pts, 22%). The most common TRAEs ≥ Grade 3 were hypertension (14 Pts, 22%) and diarrhea (7 Pts, 11%).

Conclusions

X4P-001 + axitinib is well tolerated in Pts with advanced RCC with a manageable safety profile. In this population, X4P-001 + axitinib demonstrates encouraging mPFS. Therapy is ongoing and updated study results will be presented.

Clinical trial identification

X4P-001-RCCA; Release date: 7 April 2015.

Editorial acknowledgement

Timothy Henion of Acumen Medical Communications.

Legal entity responsible for the study

X4 Pharmaceuticals.

Funding

X4 Pharmaceuticals.

Disclosure

D.F. McDermott: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Exelixix; Honoraria (self), Advisory / Consultancy: Array BioPharm; Honoraria (self), Advisory / Consultancy: Genentech BioOncology; Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: EMD Serono; Research grant / Funding (institution): Prometheus Laboratories; Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy: Jounce Therapeutics. T. Ho: Advisory / Consultancy: Exelixis; Advisory / Consultancy: Ipsen Bioscience; Advisory / Consultancy: Roche; Advisory / Consultancy: Cardinal Health; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi; Research grant / Funding (institution): Novartis. B. Keam: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Merck Sharp & Dohme; Advisory / Consultancy: Genexine; Research grant / Funding (self): Ono Pharmaceutical. R. Joseph: Advisory / Consultancy: BMS; Advisory / Consultancy: Merck Sharp & Dohme; Advisory / Consultancy: Array. W. Stadler: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Caremark/CVS; Advisory / Consultancy, Research grant / Funding (institution): Clovis; Advisory / Consultancy, Research grant / Funding (institution): Eisai; Advisory / Consultancy, Research grant / Funding (institution): Genentech; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Sotio; Speaker Bureau / Expert testimony: Applied Clinical Education; Speaker Bureau / Expert testimony: Dava Oncology; Speaker Bureau / Expert testimony: Global Academy for Medical Education; Speaker Bureau / Expert testimony: OncLive; Speaker Bureau / Expert testimony: PeerView; Speaker Bureau / Expert testimony: Vindico; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Astellas (Medivation); Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): X4 Pharmaceuticals. J. Picus: Advisory / Consultancy: NovoNordisk; Advisory / Consultancy: Sanofi; Research grant / Funding (institution): BioClin Therapeutics; Research grant / Funding (institution): Agensys; Research grant / Funding (institution): Mirati Therapeutics; Research grant / Funding (institution): Innocrin Pharmaceuticals; Research grant / Funding (institution): Rexahn Pharmaceuticals; Research grant / Funding (institution): Endocyte; Research grant / Funding (institution): Seattle Genetics; Research grant / Funding (institution): Tracon Pharmaceuticals; Research grant / Funding (institution): eFFECTOR Therpeutics. Y. Zakharia: Advisory / Consultancy: Amgen; Advisory / Consultancy: Roche Diagnostics; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Array BioPharm; Advisory / Consultancy: Eisai; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Castle Bioscience; Advisory / Consultancy: Pfizer. L. Gan: Full / Part-time employment: X4 Pharmaceuticals. M.B. Atkins: Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Novartis; Advisory / Consultancy: Arrowhead; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Genentech-Roche; Advisory / Consultancy: Galactone; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Werewolf; Advisory / Consultancy: Fathom; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Eisai; Advisory / Consultancy: Aveo; Advisory / Consultancy: Array; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Ideera; Advisory / Consultancy: Amgen; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Alexion; Advisory / Consultancy: Iovance; Advisory / Consultancy: Newlink. All other authors have declared no conflicts of interest.

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