Healthcare Industry News: orphan drug designation
News Release - August 9, 2016
AstraZeneca Provides Update On Phase III Trial Of Selumetinib In Non-Small Cell Lung CancerBOULDER, Colo., Aug. 9, 2016 -- (Healthcare Sales & Marketing Network) -- AstraZeneca (LON/STO/NYSE: AZN) today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). Array BioPharma (ARRY) was informed of these results on Monday, August 8, 2016.
The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.
SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m2, on day one of every 21-day cycle).
Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received orphan drug designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.1
About Array's Agreement with AstraZeneca
AstraZeneca acquired exclusive worldwide rights to selumetinib from Array. To date, Array received $26.5 million in up-front and milestone payments and is entitled to potential additional development milestone payments of approximately $70 million (with $30 million specific for selumetinib) and royalties on product sales.
About KRASm non-small cell lung cancer
KRAS is one of the most common genetic mutations in NSCLC, and is found in 30% of patients.2 Adenocarcinomas make up the majority of cases with KRAS mutations, which are less common in squamous cell NSCLC.2,3
KRAS mutations are associated with activation of the RAS-ERK signalling pathway, which drives tumour growth.3
About selumetinib (AZD6244, ARRY-142886)
Selumetinib is an oral, potent and highly selective MEK 1/2 inhibitor. MEK 1/2 are critical components of the RAS-ERK pathway, activation of which is implicated in driving cancer growth and progression, including in patients with KRASm NSCLC.4,5
In May 2016, selumetinib was granted orphan drug designation by the US Food and Drug Administration (FDA) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC), and AstraZeneca is committed to exploring its full potential, including in Phase III trials in patients with DTC and in a US National Cancer Institute-sponsored Phase II registration trial in patients with paediatric neurofibromatosis type 1.
SELECT-1 (NCT01933932) is a Phase III, double-blind, randomised, placebo-controlled trial. It is designed to assess the efficacy and safety of selumetinib (75 mg twice daily, given orally on a continuous schedule) in combination with docetaxel (75 mg/m2 intravenously on day 1 of every 21-day cycle), compared with matched placebo in combination with docetaxel (same schedule) in 510 patients receiving 2nd-line treatment for KRASm locally advanced or metastatic NSCLC (stage IIIB-IV), confirmed by central testing of tumour tissue using the cobas® KRAS Mutation Test (Roche Molecular Systems).3
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