Endocyte Announces The Lancet Oncology Publication of Phase 2 Data From Investigator-Initiated Prostate Cancer Trial of (177)Lu-PSMA-617
-Publication includes analysis of original 30 patients previously presented at 2017 ESMO by Professor
-Relative to previously presented data, publication reflects longer median overall survival, longer median prostate specific antigen (
–PSA reduction of at least 50% from baseline in 57% of patients as originally reported–
–Response data for an additional 20 patients expected to be presented at
“This more detailed publication was consistent with or improved from the summary results presented at ESMO last fall,” said
Mr. Sherman continued, “We also look forward to Professor Hofman presenting additional updates at the
Updated Data Disclosed in The Lancet Oncology
The journal article published today in The Lancet Oncology reviews the design and results to date of the original 30 patients from this phase 2 trial. This publication provides a more comprehensive summary than previously disclosed of patient characteristics, treatment regimen and more mature outcome data, including updated Kaplan-Meier curves estimating overall survival and
This study evaluated a heavily pre-treated patient population, 87% of which had received > 1 line of prior chemotherapy (80% docetaxel and 47% cabazitaxel) and 83% received prior abiraterone acetate and/or enzalutamide.
Observations in this study include a
Notably, patients with a PSA50 response had median PSA PFS of 9.9 months and median OS of 17.0 months compared to PSA PFS of 4.1 months and median OS of 9.9 months for those who did not achieve a PSA50 response. Additionally, clinically meaningful improvements in quality of life measures were observed.
17 patients (57%) had prostate cancer working group 2 (PCWG2) RECIST 1.1 evaluable nodal or visceral target lesions following CT scan at baseline. Confirmed objective responses were seen in 14 (82%) of these 17 patients, including complete and partial response rates of 29% and 53%, respectively. This response rate is greater than the 71% PCWG2 RECIST 1.1 objective response rate previously reported.
177Lu-PSMA-617 was well tolerated, with no significant dose-limiting toxicities observed. The most common treatment-related toxicity was Grade 1 xerostomia (dry mouth) seen in 87% of patients, which is higher than previously reported (63%), but generally didn’t require any intervention. The occurrence of treatment-related Grade 3-4 hematologic toxicity was low and comparable to the largest retrospective published cohort.1
The paper is available online at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30198-0/supplemental
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, future use of capital, sufficiency of cash, the timing of initiation, interim assessments and completion of clinical trials, the enrollment period for, and availability and reporting of data from, ongoing and future clinical trials, the occurrence and timing of actions by regulatory agencies, estimates of the potential market opportunity for the company’s product candidates, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials and future sources of supply of product candidates to support clinical and commercial activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company or independent investigators may experience delays in the initiation or completion of clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that suppliers or other third party contractors may not fulfill their contractual obligations on a timely basis or at all; risks that data from prior clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company'sability to capture value for thetechnology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by
1 Rahbar K, Ahmadzadehfar J, Kratochwil C, Haberkorn U, Schäfers M, Essler M, Baum RP, Kulkarni HR, Schmidt M, Drzezga A, Bartenstein P, Pfestroff A, Luster M, Lützen U, Marx M, Prasad V, Brenner W, Heinzel A, Mottaghy FM, Ruf J, Meyer PT, Heuschkel M, Eveslage M, Bögemann M, Fendler WP, Krause BJ. German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients. J Nucl Med. 2017;58(1):85-90.
Source: Endocyte, Inc.