A randomized phase 2 trial of CRLX101 in combination with bevacizumab in patients with metastatic renal cell carcinoma (mrcc) vs standard of care
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1 A randomized phase 2 trial of CRLX101 in combination with bevacizumab in patients with metastatic renal cell carcinoma (mrcc) vs standard of care Martin H. Voss 1, Thomas Hutson 2, Arif Hussain 3, Ulka Vaishampayan 4, Nicholas Vogelzang 5, Tiffany Crowell 6, Jian Li 6, William Downing 6, Adrian Senderowicz 6, Emily Stone 6 1 Department of Medicine, GU Oncology, Memorial Sloan Kettering Cancer Center, New York, NY; 2 Texas Oncology, Dallas, TX; 3 Greenebaum Cancer Center, University of Maryland, Baltimore, MD; 4 Karmanos Cancer Institute, Detroit, MI; 5 Comprehensive Cancer Centers of Nevada, Las Vegas, NV; 6 Cerulean Pharma Inc., Waltham, MA Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA
2 Background CRLX101 is a novel investigational nanoparticle-drug conjugate (NDC) containing the payload camptothecin, a potent inhibitor of topoisomerase I which has also been shown to inhibit HIF1α and HIF2α in preclinical models 1,2 CRLX101 has been investigated in more than 400 patients as monotherapy or in combination with other anticancer agents 3-7 In a phase 1b/2 trial, CRLX101 + bevacizumab was shown to be generally well tolerated and active in patients with clear cell and non-clear cell mrcc, an HIF-overexpressing tumor type 1 Here we will report results of a randomized phase 2 trial comparing CRLX mg/m 2 + bevacizumab 10 mg/m 2 vs SOC in mrcc (randomized 1:1) 1. Lazarus D, et al. Cancer Res. 2013;73:Abstract Pham E, et al. Clin Cancer Res. 2015;21: Keefe SM, et al. Ann Oncol. 2016;27: Weiss GJ, et al. Invest New Drugs. 2013;31: Krasner CN, et al. J Clin Oncol. 2014;32:Abstract Lakani N, et al. Ann Oncol. 2016;27:Abstract 393P. 7. Krasner CN, et al. Ann Oncol. 2016;27:Abstract 864P. CD, cyclodextrin; CPT, camptothecin; HIF, hypoxia-inducible factors; PEG, polyethylene glycol; SOC, standard of care. 2
3 Study Design Age 18 years Key Eligibility Criteria Histologically or cytologically confirmed mrcc of any pathology RECIST evaluable, unresectable disease 2 3 lines of prior therapy ECOG Performance Status 1 Patient Stratification Patients were stratified by: - mtor inhibitor as a prior line of therapy - 3 prior lines of therapy - Non-clear cell RCC histology Treatment CRLX101/Bevacizumab or SOC (1:1) 28-day cycles CRLX101/Bevacizumab Arm CRLX mg/m 2 (IV days 1 and 15) Bevacizumab 10 mg/m 2 (IV days 1 and 15) SOC Arm Physician s choice, including: - Axitinib - Bevacizumab - Everolimus - Pazopanib - Sorafenib - Sunitinib - Other approved drug considered an acceptable SOC Endpoints Primary endpoint: Independent radiological review of PFS in patients with clear cell mrcc (CRLX101/bevacizumab vs SOC) - Tumor evaluation every 8 weeks per RECIST v.1.1 Key secondary endpoints: Local radiological review of PFS in patients with clear cell mrcc (CRLX101/bevacizumab vs SOC) Independent and local radiological review of PFS in patients with clear cell mrcc (CRLX101/bevacizumab vs bevacizumab treatment alone) Independent and local assessment of ORR and DOR in patients with clear cell mrcc (CRLX101/bevacizumab vs SOC) DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; IV, intravenous; mtor, mechanistic target of rapamycin; ORR, objective response rate; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors. 3
4 Patient Demographics Characteristic CRLX101/Bevacizumab Arm (N = 56) SOC Arm (N = 59) Age, median (range) 65 (36 84) 60 (25 81) Sex (%) Male 39 (69.6) 41 (69.5) Female 17 (30.4) 18 (30.5) MSKCC prognostic risk category (%) Favorable 16 (28.6) 19 (32.2) Intermediate 25 (44.6) 28 (47.5) Poor 11 (19.6) 7 (11.9) Missing 4 (7.1) 5 (8.5) ECOG performance status (%) 0 24 (42.9) 22 (37.3) 1 32 (57.1) 35 (59.3) Missing 0 2 (3.4) Clear cell pathology, n (%) 50 (89.3) 52 (88.1) Two or more prior lines of therapy, n (%) 55 (98.2) 58 (98.3) Therapies Received in SOC Arm (N = 56*) Axitinib 18 (32.1) Bevacizumab 19 (33.9) Everolimus 7 (12.5) Pazopanib 4 (7.1) Sorafenib 4 (7.1) Sunitinib 2 (3.6) Temsirolimus 2 (3.6) *Three enrolled patients in this arm did not receive treatment on study. Data cutoff date: August 2, MSKCC, Memorial Sloan-Kettering Cancer Center. 4
5 Independent Radiological Review of PFS: Patients with Clear Cell mrcc CRLX101/Bevacizumab Arm vs SOC Arm HR (95% CI) Median PFS, mo (95% CI) CRLX101/Bevacizumab (N = 50*) 3.7 ( ) SOC (N = 52*) 3.9 ( ) P value 1.25 ( ) *Patients who received 1 dose of drug. Data cutoff date: August 2, Bev, bevacizumab; CI, confidence interval; HR, hazard ratio; mo, months. 5
6 Independent Radiological Review of PFS: Patients with Clear Cell mrcc Combination vs Bevacizumab Alone Median PFS, mo (95% CI) CRLX101/Bevacizumab (N = 50*) 3.7 ( ) Bevacizumab Alone (N = 17*) 3.4 ( ) CRLX101/Bevacizumab Arm vs Bevacizumab-alone Cohort HR (95% CI) P value 1.14 ( ) *Patients who received 1 dose of drug. Data cutoff date: August 2,
7 Independent Assessment of ORR: Patients with Clear Cell mrcc Parameter RECIST ORR CRLX101/Bevacizumab (N = 42*) 2 (4.8) [ ] n (%) [95% CI] SOC (N = 43*) 6 (14.0) [ ] P = CR 0 2 (4.7) PR 2 (4.8) 4 (9.3) SD 23 (54.8) 24 (55.8) PD 15 (35.7) 13 (30.2) Non-CR/non-PD 1 (2.4) 0 NE 1 (2.4) 0 *Patients who received 1 dose of drug and had baseline and postbaseline scans. Per RECIST v1.1, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits in patients without target lesion(s) at baseline. Data cutoff date: August 2, CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; ORR, objective response rate; SD, stable disease. 7
8 Most Common Treatment-emergent AEs ( 10% Any Grade in Either Arm) CRLX101/Bevacizumab (N = 55*) SOC (N = 56*) Any Grade Grade 3/4 Any Grade Grade 3/4 AE n (%) Fatigue 21 (38.2) 4 (7.3) 19 (33.9) 3 (5.4) Nausea 16 (29.1) 0 13 (23.2) 1 (1.8) Constipation 10 (18.2) 0 4 (7.1) 0 Anemia 8 (14.5) 3 (5.5) 5 (8.9) 1 (1.8) Cystitis noninfective 7 (12.7) Decreased appetite 7 (12.7) 0 7 (12.5) 0 Diarrhea 6 (10.9) 0 13 (23.2) 0 Epistaxsis 6 (10.9) 0 2 (3.6) 0 Headache 6 (10.9) 1 (1.8) 4 (7.1) 0 Proteinuria 6 (10.9) 0 8 (14.3) 0 Dysphonia 4 (7.3) 0 8 (14.3) 0 Stomatitis 4 (7.3) 0 8 (14.3) 1 (1.8) Hypertension 3 (5.5) 3 (5.5) 13 (23.2) 4 (7.1) Vomiting 3 (5.5) 1 (1.8) 7 (12.5) 3 (5.4) Palmar-plantar erythrodysesthesia syndrome 1 (1.8) 0 7 (12.5) 1 (1.8) Rash 1 (1.8) 0 6 (10.7) 1 (1.8) *Patients who received 1 dose of drug. Data cutoff date: August 2, AE, adverse event. 8
9 Conclusions The current trial did not demonstrate a statistically significant improvement in PFS for the CRLX101 + bevacizumab combination vs SOC in patients with clear cell mrcc The combination was generally well tolerated and comparable to earlier experience with no new safety signals identified While there are no plans for further development of this combination in mrcc, ongoing trials with CRLX101 will focus on the treatment of topoisomerase I sensitive tumor types such as ovarian and gastrointestinal tumors 9
10 Acknowledgments We thank the CRLX study patients, their families and caregivers, and the CRLX study staff and investigators for their participation. The study was sponsored and funded by Cerulean Pharma Inc. Medical writing and editorial support were provided by Nathan Yardley and Paula Stuckart of Ashfield Healthcare Communications. 10
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