QED Therapeutics Presents New Data on the Potential for Infigratinib to Treat Upper Tract Urothelial Carcinoma

SAN FRANCISCO, June 3, 2019 /PRNewswire/ -- QED Therapeutics announced today the presentation of data demonstrating the clinical activity of its investigational product infigratinib in advanced or metastatic upper tract urothelial carcinoma (UTUC) compared to urothelial carcinoma of the bladder (UCB). Data were presented in a poster discussion session during the ASCO 2019 Annual Meeting.

UTUC is a cancer of the renal pelvis or ureter. A relatively rare cancer, UTUC makes up approximately 5% to 10% of all urothelial carcinomas.¹ The prognosis for people diagnosed with UTUC is generally worse than those diagnosed with UCB.² Guidelines for the treatment of UTUC are scarce and, therefore, it is frequently treated in a similar way as UCB.³ Patients have limited treatment options for UTUC and UCB, with chemotherapy or checkpoint inhibitor therapy being the only recommended treatments for second (or later) line UCB.⁴

In the study, researchers analyzed genetic profiles for patients participating in a clinical trial studying infigratinib for the treatment of urothelial cancer and determined that patients with UTUC had a distinctly different genomic profile than those with UCB, particularly with respect to FGFR3 alterations. Efficacy was also analyzed, with clinical activity which we believe to be meaningful shown in both subgroups. In the subgroup of patients with UTUC, patients treated with infigratinib showed a 50% objective response rate (ORR) and a median overall survival of nearly 22 months. In the subgroup of patients with UCB treated with infigratinib, the ORR was 22% with a median overall survival of 7 months. ORR was calculated from the number of patients who had a confirmed complete response, plus those who had a confirmed partial response.

"We now have specific genetic data that provides insight into why cancers of the upper urinary tract behave differently from those in the bladder as well as an indication that inhibiting FGFR3 holds promise for treating this challenging cancer," said Sumanta Pal MD, head of the kidney and bladder cancer disease team at City of Hope Comprehensive Cancer Center. "While the data showing a 50% objective response rate and a nearly 22 month median overall survival for UTUC subjects treated with infigratinib represent a small sample size, they have real implications for the potential future treatment of UTUC if infigratinib is approved."

There were eight patients in the UTUC subgroup and 59 patients in the UCB subgroup. Adverse events in both subgroups were generally consistent with infigratinib's safety data from earlier clinical trials, with the exception of increases in blood creatinine among some patients. Treatment emergent adverse events occurring in >30% of patients were: blood creatinine increased (40%), fatigue (39%), hyperphosphatemia (39%), constipation (37%), anemia (36%), decreased appetite (33%), alopecia (31%), and dry mouth (31%).

QED Therapeutics plans to continue development of infigratinib for the potential treatment of urothelial carcinomas of both the upper tract and bladder. For information on the status of our development programs, please visit www.qedtx.com.

About QED Therapeutics

QED Therapeutics, a subsidiary of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Our lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that we believe to be meaningful in clinical measures such as overall response rate in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED is also evaluating infigratinib in preclinical studies for the treatment of achondroplasia. We plan to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with other FGFR-driven tumor types and rare disorders.

For more information on QED Therapeutics, please visit the company's website at www.qedtx.com.

Forward-Looking Statements 

This press release contains forward-looking statements. All statements contained herein other than statements of historical fact constitute forward-looking statements, including statements relating to expectations, plans, and prospects regarding QED Therapeutics' clinical development plans, clinical trial results, timing and completion of clinical trials, competitive environment and clinical and therapeutic potential of infigratinib. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to, QED Therapeutics' ability to initiate and continue its planned clinical trials of infigratinib, its ability to advance infigratinib in clinical development and the timing and success of any such continued clinical development. Moreover, QED Therapeutics operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of QED Therapeutics' management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. All forward-looking statements in this press release are based on information available to QED Therapeutics as of the date hereof, and QED Therapeutics disclaims any obligation to update these forward-looking statements.

¹Leow J.J., Chong K.T., Chang S.L., Bellmunt J. "Upper tract urothelial carcinoma: a different disease entity in terms of management" ESMO Open (2016):1:e000126

² Catto, J. W. F., Yates, D. R., Rehman, I., Azzouzi, A. R., Patterson, J., Sibony, M., Cussenot, O., Hamdy, F. C. "Behavior of Urothelial Carcinoma With Respect to Anatomical Location" The Journal of Urology (2007): 177(5), 1715–1720.

³Hutchinson R., Haddad A., Sagalowsky A., Margulis V. "Upper Tract Urothelial Carcinoma: Special Considerations" Clinical Advances in Hematology & Oncology (2016): 14-2.

⁴National Comprehensive Cancer Network. (2019). Bladder cancer (version 3.2019). Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf

SOURCE QED Therapeutics