0001193125-16-615285.txt : 20160607 0001193125-16-615285.hdr.sgml : 20160607 20160607160608 ACCESSION NUMBER: 0001193125-16-615285 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20160604 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160607 DATE AS OF CHANGE: 20160607 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36172 FILM NUMBER: 161701314 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 d205554d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 4, 2016

 

 

ARIAD Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36172   22-3106987

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

26 Landsdowne Street, Cambridge, Massachusetts   02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 494-0400

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


ITEM 8.01 Other Events.

On June 4, 2016, ARIAD Pharmaceuticals, Inc. (the “Company”) issued the first of three press releases announcing data presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. This press release detailed updated clinical data on the Company’s investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 8.01of this Current Report on Form 8-K.

On June 4, 2014, the Company issued a second press release announcing clinical data from an analysis aimed at characterizing the activity of brigatinib in patients with ALK+ advanced NSCLC who have progressed on crizotinib. The analysis was based on ALK mutation status as determined by next-generation sequencing of tumor tissue collected from the ongoing Phase 1/2 and ALTA clinical trials. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference into this Item 8.01of this Current Report on Form 8-K.

On June 6, 2014, the Company issued its third and final press release from ASCO announcing updated clinical data on brigatinib from the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy. The data show that, of patients on the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54 percent achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib setting. Additionally, a 67 percent confirmed intracranial objective response rate (ORR) was achieved in patients with measurable brain metastases. These data were presented for the first time on June 6th at ASCO, reflecting an additional 12 weeks of patient follow up and new data on central nervous system (CNS) activity compared to the abstract released last month. A copy of the press release is attached hereto as Exhibit 99.3 and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

 

ITEM 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

  

Description

99.1    Press release dated June 4, 2016
99.2    Press release dated June 4, 2016
99.3    Press release dated June 6, 2016

The press releases may contain hypertext links to information on our websites. The information on our websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

ARIAD Pharmaceuticals, Inc.
By:  

/s/ Manmeet S. Soni

  Manmeet S. Soni
  Executive Vice President, Chief Financial Officer

Date: June 7, 2016


Exhibit List

 

Exhibit

  

Description

99.1    Press release dated June 4, 2016
99.2    Press release dated June 4, 2016
99.3    Press release dated June 6, 2016
EX-99.1 2 d205554dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

 

News Release

 

ARIAD PRESENTS LONG-TERM PHASE 1/2 TRIAL FOLLOW UP ON

INVESTIGATIONAL DRUG BRIGATINIB WITH MEDIAN TIME ON

TREATMENT OF 17 MONTHS IN ALK+ NSCLC PATIENTS

~ Longest Time on Treatment Now More Than 3.5 Years

for Patients with ALK+ Non-Small Cell Lung Cancer

~ Data from Phase 1/2 Clinical Trial Presented at 2016 ASCO Meeting

Chicago, IL and Cambridge, MA – June 4, 2016 – ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients.

The updated Phase 1/2 results are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Phase 1/2 Study

The data presented at ASCO include safety analyses on all patients in the trial (n=137) and efficacy analyses on all patients with ALK+ NSCLC (n=79). Of the 79 ALK+ NSCLC patients, all but eight had failed prior crizotinib. The presentation is based on patient data as of November 2015 with a median time on treatment for ALK+ NSCLC patients of 17.0 months (range, 0.03 – 44.4 months, ongoing). Patient enrollment in the trial is complete, with the last patient enrolled in July 2014.

“The long-term follow up on this clinical trial of brigatinib shows substantial anti-tumor activity with an objective response rate of approximately 72 percent in crizotinib-resistant ALK-positive NSCLC patients,” stated D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the Colorado University Cancer Center. “The median progression-free survival in this post-crizotinib patient group exceeds one-year and has not yet been reached in patients not previously treated with crizotinib. Importantly, no new safety signals have emerged at this later time of follow up.”


Key data from the study include:

Anti-tumor Activity of Brigatinib in ALK+ NSCLC Patients

 

    Of the 71 ALK+ NSCLC patients with prior crizotinib therapy, 51 (72%) demonstrated an objective response to brigatinib. Forty-four responses were confirmed (62%).

 

  ¡    Of the 25 patients treated at the 180 mg dose regimen that included a seven-day lead-in dose of 90 mg, 20 (80%) demonstrated an objective response, of which 19 (76%) were confirmed.

 

    Of the eight crizotinib-naive ALK+ NSCLC patients treated with brigatinib, all demonstrated an objective response (100%), including three complete responses (CR). All responses were confirmed.

 

    The “waterfall plot” analysis demonstrated tumor shrinkage in nearly all ALK+ NSCLC patients, with 21 patients experiencing 100 percent shrinkage of the target lesions.

 

    The median duration of response in confirmed responders was 14.5 months in ALK+ NSCLC patients treated with prior crizotinib therapy and was not yet reached in ALK+ NSCLC patients who were crizotinib-naive.

 

    Median progression-free survival (PFS) was 12.9 months in ALK+ NSCLC patients with prior crizotinib therapy and was not yet reached in ALK+ NSCLC patients who were crizotinib-naive.

 

    Overall survival (OS) at one year was 77 percent in patients who received prior crizotinib (projected 2-year OS was 63%) and 100 percent in patients who were crizotinib-naive (projected 2-year OS was 100%).

An evaluation of the efficacy of brigatinib in ALK+ NSCLC patients with intracranial CNS metastases at baseline was also included in the ASCO presentation. In an independent central review of brain magnetic resonance imaging (MRI) scans, 46 ALK+ NSCLC patients were evaluable for intracranial response, including 15 who had measurable intracranial

 

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CNS metastases at baseline, and 31 patients who had only non-measurable intracranial CNS metastases.

 

  ¡    10 of 15 (67%) patients with measurable intracranial CNS metastases had an intracranial objective response, and 13 of 31 (42%) with only non-measurable intracranial CNS metastases had complete disappearance of intracranial lesions.

 

  ¡    Median intracranial PFS for ALK+ NSCLC patients with intracranial CNS metastases at baseline was 15.6 months. Median duration of intracranial response in confirmed responders was 11.4 months.

Safety and Tolerability – All Patients Enrolled

 

    The most common treatment-emergent adverse events (AEs; ³ 30%), regardless of relationship to treatment, in all patients were nausea (51%), fatigue (42%), diarrhea (41%), headache (34%), and cough (33%).

 

    Treatment-emergent AEs, regardless of relationship to treatment, grade 3 or higher, occurring in ³4% patients were increased lipase (9%), dyspnea (7%), hypertension (5%), increased amylase (4%), and fatigue (4%)

 

    Serious treatment-emergent AEs, regardless of relationship to treatment, occurring in three or more patients were dyspnea (7%), pneumonia (7%), hypoxia (5%), pulmonary embolism (3%), malignant pericardial effusion (2%), and pneumonitis (2%).

 

    A subset of pulmonary AEs (including dyspnea, hypoxia, pneumonia and/or pneumonitis) was observed to occur within 7 days of treatment initiation or treatment re-initiation following a prolonged dose interruption. Most events occurred within 48 hours of dosing and were generally managed with dose interruption or discontinuation.

 

  ¡    Rates of these AEs were numerically lower with lower starting doses (11/137 [8%], overall)

 

  ¡    6/44 (14%) in patients started at 180 mg qd

 

  ¡    1/50 (2%) in patients started at 90 mg qd

 

  ¡    Among 32 patients treated with 90 mg qd for 7 days followed by 180 mg qd, no such events were reported after dose escalation

 

    Administration of brigatinib at 180 mg with a 7-day lead-in at 90 mg appears to not be associated with an increased risk of additional early pulmonary AEs, when compared with continuous administration of brigatinib at 90 mg.

 

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About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to crizotinib. More information on brigatinib clinical trials, including the expanded access program (EAP) can be found here.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is an orphan oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other orphan cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

Forward-Looking Statements

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: updated clinical data for brigatinib and the therapeutic potential of brigatinib are forward-looking statements which are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, among others: early-stage clinical data may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the adequacy of our capital resources and the availability of additional funding; our ongoing and additional clinical trials of brigatinib may not be successful or initiated, enrolled or conducted in a timely manner; regulatory developments and safety issues; competitive risks; manufacturing issues and those additional factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-

 

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looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

 

CONTACTS:      For Investors       For Media
     Manmeet S. Soni       Liza Heapes
     Manmeet.soni@ariad.com       Liza.heapes@ariad.com
     (617) 503-7298       (617) 621-2315

###

 

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EX-99.2 3 d205554dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

 

 

News Release

 

ARIAD PRESENTS DATA FROM MUTATIONAL PROFILING IN

CRIZOTINIB-RESISTANT PATIENTS TREATED WITH INVESTIGATIONAL

MEDICINE BRIGATINIB SHOWING SIMILAR RESPONSE RATES IN

PATIENTS WITH AND WITHOUT SECONDARY ALK MUTATIONS

~ Brigatinib Achieves Confirmed Response in Patient with G1202R Mutation that Emerges

Following Treatment with Current Approved Therapies

Chicago, IL and Cambridge, MA – June 4, 2016 – ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced clinical data from an analysis aimed at characterizing the activity of its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The analysis was based on ALK mutation status as determined by next-generation sequencing (NGS) of tumor tissue collected from the ongoing Phase 1/2 and ALTA clinical trials.

Data from this analysis showed that brigatinib yields confirmed responses in patients with multiple different secondary ALK mutations, including one G1202R case. There are no currently approved ALK treatments that have demonstrated activity against the G1202R mutation.

These data are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Study Methods

Requirements for the Phase 1/2 and ALTA trials of brigatinib included that tumor tissue be collected at patient screening after failure on crizotinib therapy and prior to brigatinib treatment. An optional post-baseline tumor biopsy also was requested following disease progression on brigatinib. Tumor samples were analyzed using a NGS (next-generation sequencing) platform that examined the entire coding sequence of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer. This analysis focuses on the relationship between brigatinib clinical activity and ALK mutation status at baseline and after disease progression on brigatinib therapy.


A total of 32 baseline tumor samples from the clinical trials of brigatinib were evaluable using NGS, and a total of six post-baseline samples following disease progression on brigatinib were evaluable by NGS.

Study Results

 

    Of the 32 patients with baseline NGS data, 22 (69%) achieved a confirmed objective response on brigatinib.

 

    Of the 9 patients with secondary ALK mutations at baseline, 7 (78%) achieved a confirmed objective response on brigatinib.

 

    Of the 23 patients without secondary ALK mutations at baseline, 15 (65%) achieved a confirmed objective response rate (ORR) on brigatinib.

 

    Of the 6 patients with evaluable tissue samples collected after progression on brigatinib therapy, 5 (83%) were determined to have detectable secondary mutations in the ALK kinase domain. Three out of five of these patients had complex mutation patterns, following responses lasting 5.4, 7.4 and 28.5 months. Two out of five had single secondary ALK kinase domain mutations detected, following responses lasting 10.9 and 11 months.

 

    Of the one patient with a secondary G1202R mutation, the patient achieved a confirmed response on brigatinib and the response is on-going.

“It is encouraging that responses to brigatinib were observed in patients with crizotinib resistant ALK+ lung cancer with and without the presence of ALK resistance mutations. This is consistent with preclinical studies showing brigatinib to be a potent pan-inhibitor of all known ALK secondary resistance mutants,” stated Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer Center.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is an orphan oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other orphan cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

 

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Forward-Looking Statements

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: updated clinical data for brigatinib and the therapeutic potential of brigatinib are forward-looking statements which are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, among others: early-stage clinical data may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the adequacy of our capital resources and the availability of additional funding; our ongoing and additional clinical trials of brigatinib may not be successful or initiated, enrolled or conducted in a timely manner; regulatory developments and safety issues; competitive risks; manufacturing issues and those additional factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

 

CONTACTS:      For Investors       For Media
     Manmeet S. Soni       Liza Heapes
     Manmeet.soni@ariad.com       Liza.heapes@ariad.com
     (617) 503-7298       (617) 621-2315

###

 

3

EX-99.3 4 d205554dex993.htm EX-99.3 EX-99.3

Exhibit 99.3

 

LOGO

 

 

News Release

 

FOR IMMEDIATE RELEASE

ARIAD’S INVESTIGATIONAL MEDICINE BRIGATINIB DEMONSTRATES 54

PERCENT CONFIRMED OBJECTIVE RESPONSE RATE AND 12.9-MONTH

MEDIAN PROGRESSION-FREE SURVIVAL IN ALTA STUDY

~ 67 Percent Confirmed Intracranial Objective Response Rate

in Patients with Measurable Brain Metastases

~ Data from Pivotal Study in Refractory ALK Positive

Non-Small Cell Lung Cancer Patients

~ Investor and Analyst Webcast to be Held at the 2016 ASCO Meeting Today at 7 a.m. CT

Cambridge, MA, June 6, 2016 – ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy. The data show that, of patients on the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54 percent achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib setting. Additionally, a 67 percent confirmed intracranial objective response rate (ORR) was achieved in patients with measurable brain metastases. These data will be presented today, for the first time, at the Annual Meeting of the American Society of Clinical Oncology (ASCO), reflecting an additional 12 weeks of patient follow up and new data on central nervous system (CNS) activity compared to the abstract released last month.

“Most patients with ALK-positive non-small cell lung cancer who are treated with crizotinib eventually experience disease progression, often due to acquired ALK resistance mutations or metastases in the central nervous system,” said presenting author Dong-Wan Kim, M.D., Ph.D., head of the Cancer Clinical Trials Center at the Seoul National University Hospital in South Korea. “For these patients, we are very excited by the brigatinib ALTA trial data, which showed compelling efficacy and safety data, including complete responses and activity in the CNS.”

The ALTA trial

The primary endpoint of the ALTA (ALK in Lung Cancer Trial of AP26113) trial is investigator-assessed confirmed objective response rate (ORR) as measured by the


 

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Response Evaluation Criteria in Solid Tumors (RECIST). Key secondary endpoints include progression free survival (PFS), confirmed ORR assessed by an independent review committee (IRC), CNS response (IRC-assessed intracranial ORR and PFS), overall survival, safety and tolerability. Brigatinib was granted the U.S. Food and Drug Administration (FDA) Orphan Drug designation for ALK+ non-small cell lung cancer (NSCLC) and the FDA Breakthrough Therapy designation for the treatment of patients with ALK+ non-small cell lung cancer (NSCLC) that is resistant to crizotinib.

The trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on crizotinib. Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD with a seven day lead-in at 90 mg QD (Arm B).

In addition, patients were stratified by the presence of brain metastases at baseline and best response to prior crizotinib.

Key Data from the ALTA Trial

Brigatinib Efficacy and Safety in ALK+ NSCLC Patients:

Data as of February 29, 2016

 

    A total of 222 patients with ALK+ NSCLC treated with prior crizotinib therapy were randomized in the study (110 patients in Arm B at the 180 mg dose level with 7-day lead-in at 90 mg and 112 patients in Arm A at the 90 mg dose level). The last patient enrolled in the study in September 2015.

 

    The median follow-up was 8.3 months in Arm B (range 0.1–20.2) and 7.8 months in Arm A (range 0.1–16.7).

 

    Investigator-assessed confirmed ORR in Arm B was 54 percent, including four complete responses. Confirmed ORR in Arm A was 45 percent, including one complete response.

 

    Responses in Arm B included a confirmed partial response in a patient with the ALK kinase domain G1202R mutation at baseline, which is associated with resistance to all approved tyrosine kinase inhibitors (TKIs).

 

    Median PFS was 12.9 months and 9.2 months in Arm B and Arm A, respectively. Probability of overall survival (OS) at 1-year was 80 percent and 71 percent in Arm B and Arm A, respectively.

 

    An evaluation of the efficacy of brigatinib in ALK+ NSCLC patients with intracranial CNS metastases at baseline was also included in the ASCO presentation.


 

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  ¡    In an independent central review of brain magnetic resonance imaging (MRI) scans, 18 patients in Arm B and 25 patients in Arm A were identified as having measurable CNS metastases at baseline.

 

  ¡    Among patients with measurable CNS metastases at baseline, the IRC-assessed confirmed intracranial ORR was 67 percent (12/18) in Arm B and 36 percent (9/25) in Arm A; among the subset of patients with measurable, active brain metastases, confirmed intracranial ORR was 73 percent (11/15) in Arm B and 36 percent (7/19) in Arm A. Measurable, active brain metastases are defined as having had no prior radiotherapy or progression following radiotherapy.

 

  ¡    Median intracranial PFS for patients with intracranial CNS metastases at baseline was not yet reached in Arm B and was 15.6 months in Arm A.

 

    The most common treatment-emergent adverse events (TEAEs; ³ 25% of all patients, [Arm B/A]), regardless of relationship to treatment, were nausea (40%/33%), diarrhea (38%/19%), cough (34%/18%), and headache (27%/28%).

 

    TEAEs, ³ grade 3, occurring in ³ 5 percent of all patients (Arm B/A), were increased blood creatine phosphokinase (9%/3%) and hypertension (6%/6%).

 

    A subset of pulmonary adverse events with early onset (median: Day 2; range: Day 1-9) occurred in 6 percent of all patients (³ grade 3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.

 

    Discontinuations and dose reductions due to AEs (Arm B/A) were 8 percent/3 percent and 20 percent/7 percent, respectively. Discontinuations due to progressive disease (Arm B/A) were 17 percent and 30 percent.

“The ALTA trial data support our planned NDA submission with a recommendation for dosing with 180 mg once daily following a seven-day lead-in at 90 mg. We are on track for submission in the third quarter,” stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. “We believe brigatinib’s antitumor activity both on disease in the lungs and in the central nervous system, safety profile, and once-daily dosing regimen taken with or without food, provide the potential for brigatinib to be an important new therapeutic option for the crizotinib-resistant patient population.”

Investor and Analyst Briefing and Webcast

A breakfast meeting featuring D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the Colorado University Cancer Center, to review the updated brigatinib clinical data from the ALTA trial will be webcast live along with slides and can be


 

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accessed by visiting the investor relations section of ARIAD’s website at http://investor.ariad.com.

 

Date:    Monday, June 6, 2016
Time:    7:00 a.m. to 8:00 a.m. (CT)
Location:    Hyatt McCormick Place

A replay of the investor event will be available on the ARIAD website approximately three hours after the presentation and will be archived on the site for four weeks. To ensure a timely connection to the live webcast, participants should log onto the webcast at least 15 minutes prior to the scheduled start time.

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to crizotinib. More information on brigatinib clinical trials, including the expanded access program (EAP) can be found here.

Brigatinib Oral Presentation

The oral presentation, “Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): first report of efficacy and safety from a pivotal randomized phase (ph) 2 trial (ALTA),” (Abstract #9007) will be presented today, Monday, June 6 in the Arie Crown Theater at 11:57 a.m. CT.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is an orphan oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other orphan cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).


 

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Forward-Looking Statements

This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to the statements made by Drs. Kim and Clackson, are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to, our ongoing strategic review, our ability to successfully commercialize and generate profits from sales of Iclusig and our product candidates, if approved; competition from alternative therapies; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

 

CONTACTS:      For Investors       For Media
     Manmeet S. Soni       Liza Heapes
     Manmeet.soni@ariad.com       Liza.heapes@ariad.com
     (617) 503-7298       (617) 621-2315

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