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JUNE 2017    A Monthly Review of Articles of Interest for the Clinical Community

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<This Month's Clinical Focus:>

<GASTROENTEROLOGY>

 

Encouraging Survival Data Observed in Patients with Advanced Pancreatic Cancer


ARMO BioSciences AM0010 (pegilodecakin, PEGylated Interleukin-10) is being evaluated in an ongoing Phase 1b clinical trial that has enrolled 352 advanced cancer patients.

 

"We are very encouraged that our novel immunotherapy AM0010 in combination with FOLFOX induced prolonged objective responses, including partial and complete responses, and led to a median overall survival of 10.0 months in patients with advanced pancreatic cancer that previously had been treated with a median of two prior therapies," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences.  "We are excited to conduct our ongoing pivotal Phase 3 clinical trial of AM0010 in combination with FOLFOX as second-line therapy for advanced metastatic pancreatic cancer. We are committed to our goal of developing new immune-based treatment options for patients living with difficult-to-treat solid tumors."

pen-tablet-table By Pressfoto at Freepik LIC CC0

Phase 1b Clinical Trial Results in Advanced Pancreatic Cancer
In this ongoing Phase 1/1b clinical trial, 47 patients with advanced pancreatic ductal adenocarcinoma (PDAC) have been treated with either AM0010 alone or AM0010 in combination with FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) chemotherapy.  In this trial, 21 patients with PDAC who had not received a prior platinum containing regimen were treated with AM0010 in combination with FOLFOX.  The patients had progressed previously on a prior gemcitabine-containing regimen and had a median number of 2 prior therapies (ranging from 1 to 5 therapies).  In this ongoing Phase 1/1b clinical trial, the median progression-free survival was 3.5 months and the estimated median overall survival was 10.0 months, with a median follow-up of 11.0 months (ranging from 5.8 to 16.3 months).  The one-year survival rate estimated by the Kaplan-Meier method is 43%. Patients with a higher number of intra-tumoral CD8+ T cells had longer median overall survival.  Of the 19 patients evaluable for tumor responses, 16% had objective responses, including 2 compete responses, and 58% had stable disease for 8 weeks or longer.  The 22 patients with advanced PDAC treated with AM0010 monotherapy had a median number of 3 prior therapies (ranging from 2-6 therapies) and the median overall survival (OS) was 3.8 months. In addition, 4 patients (18%) remain alive for more than one year, with 2 of 4 alive more than 18 months after starting treatment.

AM0010 treatment was well tolerated in advanced pancreatic cancer patients either alone or in combination with FOLFOX.  Grade 3/4 treatment-related adverse events associated with daily dosing of AM0010 included thrombocytopenia, anemia, and neutropenia were transient and reversible.  AM0010 plus FOLFOX with a modified AM0010 dose schedule (5 days on, 2 days off) was tested without grade 3/4 adverse events.  This modified dose schedule is being used in the ongoing Phase 3 clinical trial.  See addt’l trial data in the complete article: https://repubhub.icopyright.net/freePost.act?tag=3.7537?icx_id=9418449

The U.S. Food and Drug Administration (FDA) and the European Commission (EC) have granted AM0010 Orphan Drug designation for the treatment of pancreatic cancer. The FDA also granted Fast Track designation for AM0010 in combination with FOLFOX as a second-line therapy in patients with pancreatic cancer.  For complete trial information, please visit www.clinicaltrials.gov (NCT02923921)


Reprinted with permission from PRNewswire via RePubHub
 


New Phase 1 Clinical Data for BLU-285 in Advanced Gastrointestinal Stromal Tumors

 

New Phase 1 clinical data and outlined registration plans for BLU-285, a potent and highly selective PDGFRα and KIT inhibitor in development as a potential treatment for patients with advanced gastrointestinal stromal tumors (GIST).

ResearchLab medic-563423_1920 at Pixabay LIC CC0In patients with PDGFRα-driven GIST harboring a D842 mutation, the data showed an objective response rate (ORR) of 60 percent and an estimated 9-month progression free survival (PFS) of 87 percent. Among patients with treatment-resistant KIT-driven GIST, tumor reduction was observed in eight of 14 evaluable patients treated at dose levels of at least 300 mg once daily (QD). BLU-285 was well tolerated, and most adverse events (AEs) reported by investigators were Grade 1 or 2.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to BLU-285 for the treatment of patients with unresectable or metastatic PDGFRα D842V-driven GIST, and the Company plans to pursue expedited development of BLU-285 in this population. Based on feedback from the FDA at a recent End-of-Phase 1 meeting, additional data from the expansion portion of the ongoing Phase 1 clinical trial of BLU-285 may be sufficient to support a New Drug Application (NDA) for the treatment of patients with PDGFRα D842V-driven GIST.

Blueprint Medicines currently estimates it will complete enrollment of the PDGFRα D842V expansion cohort, which is expected to include approximately 50 patients, by the middle of 2018. The Company also plans to initiate a global, pivotal Phase 3 clinical trial of BLU-285 in the first half of 2018, with the goal of supporting the registration of BLU-285 in a broader GIST patient population.  

"The new data announced today reinforce the clinical potential of BLU-285 in these populations. High response rates and prolonged progression free survival suggest BLU-285 has the potential to transform the treatment of PDGFRα D842-driven GIST. In addition, BLU-285 showed very encouraging anti-tumor activity in the treatment-resistant KIT-driven GIST population with a complex mutational burden, for whom disease control is a major treatment goal. Together, these results support efforts to expand the clinical development of BLU-285, including into earlier lines of GIST treatment."

About the Trial
The Phase 1 clinical trial of BLU-285 is designed to evaluate the safety and tolerability of BLU-285 in adults with advanced GIST. The trial consists of two parts, a dose-escalation portion and an expansion portion. The dose-escalation portion is complete, and the MTD has been determined to be 400 mg QD. The expansion portion is actively enrolling patients in two defined cohorts, including a cohort of patients with a PDGFRα D842V mutation, regardless of line of therapy, and a cohort of patients who have received imatinib and at least one other KIT-directed TKI. Trial objectives include assessing response, pharmacokinetics and pharmacodynamic measures. The two expansion cohorts of the trial are designed to enroll approximately 100 patients at multiple sites in the United States, United Kingdom and European Union. Please refer to www.clinicaltrials.gov for additional details related to this Ph 1 clinical trial (NCT02508532). Patients and physicians may contact studydirector@blueprintmedicines.com  for more info on this Ph 1 trial. Addt’l data reported in the complete article: http://ir.blueprintmedicines.com/phoenix.zhtml?c=253931&p=irol-newsArticle&ID=2278748


Displayed with permission from PR Newswire


Image credits: Computer provided by Pressfoto at Freepik LIC CC0 license from  and Lab from Pixabay LIC CC0

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