Tesaro's Rolapitant: Competition for Emend

  • ID: 2673546
  • Report
  • 26 Pages
  • LifeTech Research
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Tesaro’s rolapitant is a NK-1 inhibitor in phase III trials for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). As such, it will compete most directly against Emend, Merck’s first-in-class NK-1 inhibitor, originally approved in 2003.

Both agents attempt to address a relatively unmet need for effective prophylaxis against the CINV that occurs during the period from 24+ to 120 hours after higly-emetogenic chemotherapy is administered (Delayed Phase). Current 5-HT3 antagonists such as Zofran, Aloxi, and Kytril are available in generic forms and provide reasonable efficacy during the Acute Phase (0 to 24 hours after chemotherapy).

This report reviews the underlying rationale for NK-1 therapy, the available phase II rolapitant data and the probability of phase III success, the history of relevant precedents and the probability of regulatory success, and importantly, rolapitant’s ability to compete against Emend in the marketplace.
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INTRODUCTION

CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV):

1. Mechanisms
2. Classification of emetic risk and therapy

ROLAPITANT:

1. Rationale for use
2. Post-operative nausea and vomiting
3. Phase II trial in CINV
4. Phase III trials

CLINICAL AND REGULATORY DISCUSSION:

1. Will the phase III trials show positive efficacy outcomes?

2. Are there safety concerns?
- Clinical data from the meta-analysis and from Emend seem to confirm a benign profile
- The pharmacology of NK-1 inhibition suggest benefit and risk
- Precedents also suggest some risks
- In summary

3. Will the rolapitant program provide adequate support for approval?
- General considerations
- The Emend precedent

MARKET OPPORTUNITY:

1. Overview

2. Competitive analysis

3. Pipeline

SUMMARY OPINION:

APPENDIX 1. Risk of emesis with chemotherapeutic agents

APPENDIX 2. ASCO CINV treatment guidelines

APPENDIX 3. Therapy regimens used in rolapitant and Emend trials

APPENDIX 4. Rolapitant phase II CINV trial results: Cycle 1 complete response rates by dose and phase

APPENDIX 5. Treatment-emergent/related adverse events with =2% incidence during the phase II CINV rolapitant trial (all cycles)

APPENDIX 6. Percent of patients with adverse events in the two pivotal oral regimen emend trials combined: cycle 1, hec setting, incidence =3%
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- Dr. Ellen Brady

- Dr. Ilana Fogelman
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