Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Corporate Update (November 2018)
12 slides from Halozyme Therapeutics's corporate update, Nov 26, 2018
Slide 1: HALO-301 Trial Update
HALO-301 Trial Update November 26, 2018 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include possible activity, benefits and attr
Slide 3: Summary
Summary Agreement reached with FDA to change the primary endpoint of HALO-301 to a single primary endpoint, Overall Survival (OS) Company and advisors remain blinded to all efficacy data Additional statistical plan changes: No interim analysis Target number of OS events for final analysis, unchanged
Slide 4: Original Design HALO-301: Overview
Original Design HALO-301: Overview Two primary endpoints: Progression Free Survival (PFS) and Overall Survival (OS) Adaptive design: at time of PFS final analysis, iDMC will recommend target number of events for final OS analysis PEGPH20 + ABRAXANE® + gemcitabine (PAG) ABRAXANE® + gemcitabine (AG) +
Slide 5: Original Design HALO-301: Statistics and Timing Assumptions
Original Design HALO-301: Statistics and Timing Assumptions Analysis Sample Size Events (%) Alpha Level (2-sided) Significant HR (minimal observable difference in months for statistical significance ) Statistical Power Timeline assumptions to events in March 2016 Original Design (PFS & OS as two pri
Slide 6: FDA Provided Feedback on Original Design in Type B Meeting March 2015
FDA Provided Feedback on Original Design in Type B Meeting March 2015 FDA feedback on PFS as an endpoint with potential to support a marketing application: “FDA did not object to the proposal to retain PFS as a co-primary endpoint. However, the ability of the PFS results to support a marketing appli
Slide 7: Key Timeline and Events
Key Timeline and Events August 2018 September 2018 October 2018 November 2018 December 2018 Initiated statistical review in anticipation of upcoming data analysis: PFS events projected December 2018-February 2019 Engaged external regulatory and statistical advisers Submitted Type C request, includin
Slide 8: Time Difference to Target PFS and OS Events Considerably Shortened, Triggering Review of Plan
Time Difference to Target PFS and OS Events Considerably Shortened, Triggering Review of Plan Events Original Projected Timeline August 2018 Projected Timeline (570 to be enrolled) Expected target 226 PFS events April 2018 Dec. 2018 - Feb. 2019 Expected target 330 OS Events August 2019 August 2019 T
Slide 9: Higher Than Projected PFS Event Censoring Resulting in Longer Time to Target PFS Events
Higher Than Projected PFS Event Censoring Resulting in Longer Time to Target PFS Events Multiple definitions are used for PFS in oncology registration trials HALO-301 PFS definition (determined acceptable by FDA): The time from randomization until the first occurrence of radiological disease progres
Slide 10: Agreement Reached with FDA to Change the Primary Endpoint of HALO-301 to a Single Endpoint, Overall Survival
Agreement reached with FDA, to change the primary endpoint of HALO-301 to a single primary endpoint, Overall Survival (OS) Additional statistical plan changes: No interim analysis 2-sided alpha of 0.05 for OS primary endpoint Target number of OS events for final analysis, unchanged at 330, projected
Slide 11: Final Analysis Plan for HALO-301
Final Analysis Plan for HALO-301 Analysis Sample Size Events (%) Alpha Level (2-sided) Significant HR (minimal observable difference in months for statistical significance ) Statistical Power Projected Events Achieved (~500 enrolled) Final OS 330 (100%) 0.05 0.795 (2.2) 93% for HR=0.67 Aug. - Nov. 2
Slide 12: Final Analysis Approach: Potential Benefits
Final Analysis Approach: Potential Benefits Full FDA and MAA approval pathway, with Overall Survival endpoint Mature data set, maximizing ability to observe treatment effect High probability of definitive HALO-301data in 2H 2019
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