On May 9, 2018 Array BioPharma Inc., (Nasdaq: ARRY) reported results for its third quarter of fiscal 2018 and provided an update on the progress of its key clinical development programs (Press release, Array BioPharma, MAY 9, 2018, View Source [SID1234526313]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Preparations for the anticipated U.S. launch of encorafenib and binimetinib in BRAF-mutant melanoma are well underway," said Ron Squarer, Chief Executive Officer. "We are pleased to have our entire commercial leadership and infrastructure in place and are poised for an exciting 2018, as we look ahead to commercialization and additional data updates from our encorafenib and binimetinib clinical trials."
COLUMBUS PHASE 3 TRIAL
Regulatory
Array’s New Drug Applications (NDAs) to support use of the encorafenib and binimetinib combination for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma remain under review by the FDA with a target action date under Prescription Drug User Fee Act (PDUFA) of June 30, 2018.
The European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), are reviewing the Marketing Authorization Applications (MAAs) submitted by Pierre Fabre and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the Manufacturing and Marketing Approval (MMA) applications submitted by Ono Pharmaceutical Co, Ltd.
The regulatory submissions were based on findings from the pivotal Phase 3 COLUMBUS trial.
COLUMBUS Median Overall Survival Results
Array will announce additional results from the Phase 3 COLUMBUS trial in an oral presentation (Abstract #223875) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting on June 4.
Array previously announced that treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, (95% CI 0.47, 0.79, p<0.001)] in patients with BRAF-mutant melanoma in the Phase 3 COLUMBUS trial.
•
The Phase 3 trial showed mOS of 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.
Exhibit 99.1
•
As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%). The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available BRAF+MEK-inhibitor treatments for patients receiving the combination of encorafenib and binimetinib included: rash (22%), pyrexia (18%), serous retinopathy including retinal pigment epithelial detachment (20%) and photosensitivity (5%). Full safety results of COLUMBUS Part 1 were published in The Lancet Oncology.
The Lancet Oncology Publication
Detailed results of the pivotal Phase 3 COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published online on March 21, 2018 and in the May 2018 print edition of The Lancet Oncology.
BEACON CRC PHASE 3 TRIAL
Array will present updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial at the ESMO (Free ESMO Whitepaper) 20th World Congress on Gastrointestinal Cancer June 20-23, 2018.
Array will present updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, binimetinib and cetuximab, an EGFR antagonist, in patients with BRAF-mutant CRC whose disease has progressed after one or two prior regimens at the ASCO (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium.
•
The estimated mPFS at the time of analysis was 8 months in 29 patients with BRAFV600E-mutant CRC.
•
The confirmed overall response rate (ORR) was 48% with 3 complete responses in patients with BRAFV600E-mutant CRC. Further, the ORR was 62% in the 16 patients who received only one prior line of therapy.
•
These data represent improvements compared to several approved standard of care benchmarks for this population which range between 4% to 8% ORR and 1.8 and 2.5 months mPFS. [1-4]
•
The triplet combination was generally well-tolerated. Two patients discontinued treatment due to AEs with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue, urinary tract infection, increased aspartate aminotransferase (AST) and increased blood CK.
•
Enrollment in the randomized portion of BEACON CRC is ongoing. BRAF mutations are estimated to occur in 10% to 15% of patients with CRC and represent a poor prognosis for these patients.
Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.
IMMUNO-ONCOLOGY COLLABORATIONS: TRIALS ADVANCING WITH BRISTOL-MYERS SQUIBB AND MERCK; TRIAL WITH PFIZER EXPECTED TO START THIRD QUARTER OF 2018
Array is developing binimetinib in combination with PD-1/ PD-L1 checkpoint inhibitors and has announced separate, strategic collaborations with Bristol-Myers Squibb, Merck and Pfizer, but in each case, are pursuing a unique trial design to explore different clinical approaches.
Bristol-Myers Squibb
•
The clinical trial continues to advance and is designed to investigate the safety, tolerability and efficacy of binimetinib in combination with nivolumab (anti-PD-1 therapy), with and without ipilimumab (CTLA-4 antibody), in patients with advanced metastatic microsatellite stable (MSS) CRC and the presence of a RAS mutation who have received one or two prior regimens.
The trial is jointly supported by Array and Bristol-Myers Squibb and sponsored by Array.
Merck
The clinical trial continues to advance and is designed to investigate the safety, tolerability and efficacy of binimetinib in combination with pembrolizumab (anti-PD-1 therapy), with and without FOLFOX or FOLFIRI (chemotherapy) in patients with CRC whose tumors are not microsatellite instability-high (MSI-H).
The trial is sponsored and funded by Merck, with Array providing binimetinib supply.
Pfizer
The clinical trial is designed to investigate the safety, tolerability and efficacy of several novel anti-cancer combinations, including binimetinib, avelumab (anti-PD-L1 therapy) and talazoparib (PARP inhibitor) across various tumor types and is expected to begin during the third quarter of 2018.
Exhibit 99.1
Initially, the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, with additional indications being explored at a later stage.
The trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.
FINANCIAL HIGHLIGHTS
Novartis Financial Commitment
Novartis continues to substantially fund all ongoing trials with encorafenib and binimetinib that were active or planned as of the close of the Novartis Agreements in 2015, including the COLUMBUS Phase 3 trial. Reimbursement revenue from Novartis was approximately $87 million for the 12 months ended March 31, 2018, of which $24.8 million was recorded in the quarter ended March 31, 2018. Total revenue and upfront payment collected from Novartis since the start of the 2015 agreement is $373.5 million.
Third Quarter of Fiscal 2018 Compared to Second Quarter of Fiscal 2018 (Sequential Quarters Comparison)
· Revenue for the third quarter of fiscal 2018 was $66.4 million, compared to $42.2 million for the prior quarter. The increase was primarily due to an upfront license fee from ASLAN Pharmaceuticals as well as higher Novartis reimbursement revenue.
· Cost of partnered programs for the third quarter of fiscal 2018 was $17.7 million, compared to $13.7 million for the prior quarter. The increase was primarily due to higher costs incurred for the BEACON CRC trial as it continues to advance, as well as additional resources engaged on collaborations.
· Research and development expense for proprietary programs was $53.6 million, compared to $42.6 million in the prior quarter. The increase was driven by higher activity on the Novartis transitioned studies and pre-commercial manufacturing costs for encorafenib and binimetinib.
· Loss from Operations for the quarter was $21.8 million, compared to a loss from operations of $25.7 million in the previous quarter. The decrease in net loss was primarily due to increased revenue, which was partially offset by increased research and development expense.
· Net loss for the second quarter was $22.9 million, or ($0.11) per share, compared to $34.1 million, or ($0.17) per share, in the prior quarter.
· Cash, Cash Equivalents and Marketable Securities as of March 31, 2018 were $440 million.
Third Quarter of Fiscal 2018 Compared to Third Quarter of Fiscal 2017 (Prior Year Comparison)
· Revenue for the third quarter of fiscal 2018 increased by $33.1 million compared to the same quarter of fiscal 2017. The increase was primarily due to the ASLAN Pharmaceuticals upfront license fee.
· Cost of partnered programs increased $10.3 million compared to the third quarter of fiscal 2017. The increase was primarily due to higher costs incurred for the BEACON CRC trial, as well as more resources engaged on collaborations.
· Research and development expense for proprietary programs increased $7.6 million, compared to the third quarter of fiscal 2017. The increase was driven by higher activity on the Novartis transitioned studies and pre-commercial manufacturing costs for encorafenib and binimetinib.
•
Net loss for the third quarter of fiscal 2018 was $22.9 million, or ($0.11) per share, compared to $35.3 million, or ($0.21) per share, for the same quarter in fiscal 2017. The decrease in net loss was primarily due to increased revenue, which was partially offset by increased research and development expense.
CONFERENCE CALL INFORMATION
Array will hold a conference call on Wednesday, May 9, 2018 at 9:00 a.m. Eastern Time to discuss these results and provide an update on the progress of its key clinical development programs. Ron Squarer, Chief Executive Officer, will lead the call.
Date: Wednesday, May 9, 2018
Time: 9:00 a.m. Eastern Time
Toll-Free: (844) 464-3927
Toll: (765) 507-2598
Pass Code: 6465079
Webcast, including Replay and Conference Call Slides:
View Source