AstraZeneca startar kliniskt fas 3 program för selumetinib, en behandling under utveckling för patienter med icke-småcellig lungcancer

AstraZeneca meddelar idag att den första patienten har randomiserats till det kliniska fas 3 programmet för selumetinib, en oral, potent, selektiv MEK-hämmare, vilken utvecklas som andra linjens behandling för patienter med avancerad eller metastaserad icke-småcellig lungcancer (non-small-cell lung cancer, NSCLC) med tumörer som har KRAS mutationer.

Studien, SELumetinib Evaluation as Combination Therapy-1 (SELECT-1), är en randomiserad, dubbel-blind, placebo-kontrollerad studie som utvärderar säkerheten och effekten hos selumetinib i kombination med docetaxel, som andra linjens behandling av lokal avancerad eller metastaserad NSCLC med KRAS mutationer. Studien är utformad för att kunna utvärdera progressionsfri överlevnad (Progression Free Survival, PFS) samt generell överlevnad (Overall Survival,OS). SELECT-1 kommer att bli den största prospektiva studien som någonsin utförts i denna patient grupp, en genetisk undergrupp av lungcancer behäftad med dålig prognos och begränsade behandlingsmöjligheter.

Beslutet att gå vidare med selumetinib till fas 3-studier på NSCLC bygger på resultaten från Study 16, en randomiserad fas 2-studie som utvärderar kombinationen av selumetinib med standardbehandlingen docetaxel, mot enbart docetaxel i KRAS-mutationpositiv NSCLC. Studie 16 visar en hög och varaktig svarsfrekvens på 37,2% jämfört med 0% (p

AstraZeneca förvärvade exklusiva globala rättigheter till selumetinib från Array BioPharma (Nasdaq: ARRY) 2003.

"Så vitt vi vet kommer SELECT-1 bli den första fas 3-studien för att undersöka om en MEK-hämmare i kombination med kemoterapi är överlägset enbart kemoterapi vid KRAS-mutationpositiv avancerad eller metastaserad icke-småcellig lungcancer. Detta är ett område där det kliniska behovet är pressande och vårt beslut att gå vidare med selumetinib baserades på fas 2-resultat som visade lovande klinisk aktivitet hos denna grupp av patienter”, säger Antoine Yver, Vice President and Head of Oncology i AstraZenecas Global Medicines Development.

-ENDS-

NOTES TO EDITORS

About the SELECT-1 clinical programme

The SELECT-1 trial will include 220 centres globally and enroll 634 patients, who will be randomized in a ratio of 1:1 to receive either selumetinib (75mg, orally, twice daily) or matching placebo in combination with docetaxel (intravenously, 75mg / m2, on day one of every 21 day cycle).

About selumetinib

Selumetinib is an oral, potent, selective MEK inhibitor, which has been shown to be effective as monotherapy and in combination with standard chemotherapy regimens in Phase I and Phase II clinical studies across a range of solid tumours, which support the development of selumetinib in patients with MEK-dependent cancers.

MEK is part of the MAPK pathway which is frequently activated in cancer, and is elevated in many different solid tumour types, including those featuring the KRAS mutation, which is present in 20% of human cancers and 20-30% of NSCLC tumours.

AstraZeneca is also investigating the potential for selumetinib in several types of MEK-dependent cancers. A Phase II study assessing the efficacy and tolerability of selumetinib combined with radioactive iodine (RAI) as adjuvant therapy in patients with differentiated thyroid cancer with high risk of recurrence started in August 2013, and a further Phase II study assessing the clinical efficacy and tolerability in combination with dacarbazine in patients with metastatic uveal melanoma is planned to start in late 2013.

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage development company and currently expects significant progress toward generating data to support our upcoming Phase 3 / pivotal trial decisions.   Novartis began Phase 3 trials evaluating Array-invented MEK162 in patients with NRAS-mutant melanoma in July 2013 and in patients with BRAF-mutant melanoma in October 2013.  In addition, Array began a Phase 3 trial evaluating MEK162 in patients with low-grade serous ovarian cancer under the license agreement with Novartis in June 2013.  AstraZeneca began a pivotal trial with Array-invented selumetinib in patients with thyroid cancer in May 2013 and began a Phase 3 trial in patients with non-small cell lung cancer in October 2013.  Two other wholly-owned drugs, ARRY-520 and ARRY-614, are also approaching Phase 3 or pivotal trial decisions which are expected by the end of 2013.  For more information on Array, please go to www.arraybiopharma.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

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