Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Technical Presentation (May 2015)
15 slides from Heron Therapeutics's technical presentation, May 28, 2015
Slide 1: MAGIC: A Phase 3 Study of SUSTOL in Patients Receiving Highly Emetogenic Chemotherapy
MAGIC: A Phase 3 Study of SUSTOL® in Patients Receiving Highly Emetogenic Chemotherapy Positive Top-Line Results May 28, 2015
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the development, regulatory approval, manufacture, la
Slide 3: SUSTOL Background
SUSTOL Background • SUSTOL® (granisetron injection, extended release) is an injectable, extended-release formulation of granisetron that utilizes Heron’s proprietary Biochronomer® drug delivery technology • Granisetron is a widely used 5-HT3 antagonist approved for the prevention of chemotherapy ind
Slide 4: SUSTOL 5-Day Profile: Granisetron Pharmacokinetics
SUSTOL 5-Day Profile: Granisetron Pharmacokinetics Granisetron is released rapidly following injection of SUSTOL and continues to be released for 5 days, providing long-acting coverage for CINV Plasma concentration of granisetron (ng/mL) 20 15 All subjects (n= 18) mean ± SEM 10 5 Minimum therapeutic
Slide 5: Rationale for Pursuing HEC Study
Rationale for Pursuing HEC Study • No 5-HT3 antagonist has demonstrated efficacy in delayed nausea and vomiting in patients receiving HEC • There is a significant unmet medical need for better prophylaxis against delayed nausea and vomiting in patients receiving HEC • Reanalysis of prior Phase 3 stu
Slide 6: Reanalysis of Prior Phase 3 Study Using ASCO 2011 Guidelines
Reanalysis of Prior Phase 3 Study Using ASCO 2011 Guidelines Protocol-Specified HEC Population ASCO 2011 Guidelines HEC Population Benefit of SUSTOL Enhanced 100% 100% with Reanalysis 90% 90% 80.7% 81.3% Complete Response Rate Complete Response Rate 74.5% 80% 80% 64.3% 67.3% 67.4% 70% 70% 55.8% 60%
Slide 7: MAGIC Trial Background
MAGIC (Modified Absorption Granisetron In the Prevention of Chemotherapy Induced Nausea and Vomiting) Trial Background • The only Phase 3 study where the comparator arm contains the currently recommended, standard-of-care, three-drug regimen for prophylaxis in a HEC population (5-HT3 antagonist + NK
Slide 8: MAGIC Conducted Entirely in U.S. Community Oncology Centers
MAGIC Conducted Entirely in U.S. Community Oncology Centers 83 U.S. Study Sites 8
Slide 9: MAGIC Study Design
MAGIC Study Design The First Three-Drug Regimen Versus Three-Drug Regimen Efficacy Study Standard-of-Care Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d1 + fosaprepitant 150 mg IV d1 + dexamethasone 12 mg IV d1 & 8 mg PO QD d2 + 8 942 patients mg PO BID d3-4 + placebo SC d1 scheduled to receive HEC* r
Slide 10: Patient Disposition: Arms Well Balanced
MAGIC Patient Disposition: Arms Well Balanced SUSTOL Ondansetron Regimen Regimen Randomized (ITT Population) 471 471 Treated (Safety Population) 456 (96.8%) 459 (97.5%) Modified ITT Population 450 (95.5%) 452 (96.0%) Cisplatin Regimen ≥50 mg/m2 Yes 124 (27.6%) 128 (28.3%) No 326 (72.4%) 324 (71.7%)
Slide 11: Primary Analysis: SUSTOL Regimen Statistically Superior to Standard-of-Care
MAGIC Primary Analysis: SUSTOL Regimen Statistically Superior to Standard-of-Care Delayed (24 to 120 Hours) Nausea and Vomiting after HEC 80% p = 0.014 Delta = 8% Complete Response Rate 70% 64.7% 60% 56.6% 50% 40% 30% 20% 10% 0% SUSTOL Regimen Standard-of-Care Complete Response defined as no emesis
Slide 12: SUSTOL Provides an Important Benefit in Nausea Reduction and Patient QoL
SUSTOL Provides an Important Benefit in Nausea Reduction and Patient QoL Results for Delayed Phase (24 to 120 Hours) p-value1 Complete Response 0.014 Complete Control (CR plus no more than mild nausea) 0.022 No or Infrequent Nausea2 0.032 Global Satisfaction with Therapy3 0.040 1. P-values are based
Slide 13: MAGIC Safety Summary
MAGIC Safety Summary • No clinically significant differences between arms on safety – No significant differences in SAEs – No significant differences in discontinuations, or discontinuations due to adverse events • Consistent with previous trials, injection site reactions were relatively common, but
Slide 14: MAGIC Trial Summary
MAGIC Trial Summary • MAGIC is the first Phase 3 CINV study: – Using a control group that receives a standard-of-care, three-drug regimen for HEC – Conducted entirely at U.S. community oncology centers • Complete Response in delayed nausea and vomiting was significantly greater with the SUSTOL-based
Slide 15: Conclusion
Conclusion SUSTOL, as part of a three-drug regimen, is the first 5-HT3 antagonist to demonstrate superiority to a standard-of-care, three-drug regimen in delayed nausea and vomiting in patients receiving HEC • Detailed results to be presented at future medical meeting • NDA resubmission on schedule
Heron Therapeutics — Technical Presentation (May 2015) on 6ix