On December 5, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the selection of the fourth target by Bristol-Myers Squibb under the companies’ current strategic oncology collaboration established in 2014 (Press release, CytomX Therapeutics, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227453 [SID1234517019]). As a result, Bristol-Myers Squibb will pay CytomX $15 million. This constitutes the final target selection under this agreement.

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"We are thrilled with the continued progress in our alliance with Bristol-Myers Squibb that has included two new target selections this year and the recent presentations of strong preclinical proof-of-concept data for our anti-CTLA-4 Probody therapeutic program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We look forward to continued progress in each of these collaboration programs as we pursue our vision of transforming lives with safer, more effective therapies."

Investigational therapeutics developed with CytomX’s Probody platform are designed to be active in the tumor while sparing healthy tissue. By restricting activity to the tumor microenvironment, investigational Probody therapeutics directed against both validated and novel targets have been shown preclinically to enable anti-tumor efficacy with an enhanced safety window, relative to traditional antibody-based therapies.

About the Collaboration Agreement
Under the terms of the agreement, which was entered into in May of 2014, CytomX granted Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probody therapeutics for up to four oncology targets. Bristol-Myers Squibb made an upfront payment of $50 million to CytomX in 2014, and provides research funding over the course of the research term. Upon the selection of the third and fourth targets, Bristol-Myers Squibb pays CytomX selection payments. CytomX is also eligible to receive additional preclinical payments and up to $298 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered royalties rising from mid-single digit to low double digits on net sales of each product commercialized by Bristol-Myers Squibb.

On December 5, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the presentation of updated safety and efficacy data from two ongoing phase 2 clinical studies evaluating MOR208, an Fc-modified investigational antibody targeting CD19, in patients with advanced B-cell malignancies, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California/USA (Press release, MorphoSys, DEC 5, 2016, View Source [SID1234516968]).

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Continued long-lasting responses of more than 26 months reported in patients with relapsed/refractory NHL in a phase 2a trial with MOR208 monotherapy

An oral presentation reported data from a phase 2a study evaluating single-agent MOR208 in 92 patients with various subtypes of relapsed or refractory non-Hodgkin’s lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and other indolent NHL (iNHL). Results were consistent with prior updates from the study, reflecting in particular a continuation of long-lasting responses of more than 26 months.

"Patients with NHL, who are refractory or show relapse after previous anti-CD20-based therapies, have limited treatment alternatives and usually a very poor prognosis. These updated results illustrate our ongoing efforts to develop MOR208 as a potential new CD19-based antibody therapy for patients suffering from B-cell malignancies, including DLBCL, in phase 2 studies in combination with other cancer drugs," said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

At the last cutoff date, June 3, 2016, three patients with DLBCL and six with iNHL were in remission and on study treatment, with the longest responses in both subgroups ongoing for more than 26 months. Of these nine patients, seven showed complete responses and 2 experienced partial responses. The median duration of response was 20.1 months for DLBCL and not yet reached for iNHL. The overall response rate (ORR), based on complete responses (CR) and partial responses (PR), was 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively. The progression free survival (PFS) rate at 12 months was 39% in both subgroups. In addition to the patients with an objective response (PR or CR), the majority of patients with stable disease (SD) (5/6 DLBCL and 14/17 iNHL) had a reduction in target lesion size (central assessment).

PFS was similar in patients with rituximab non-refractory versus rituximab refractory tumors. Fifty-two patients (57%) in the study were classified as having rituximab refractory disease. Of those, five of 24 patients (21%) with DLBCL and five of 22 patients (23%) with iNHL responded to MOR208. Of the 10 responders with rituximab refractory disease, six had a response duration longer than 10 months, two of which lasted for more than 26 months.

The most common adverse events were infusion-related reactions (IRRs) occurring in 12% of the patients (11% of grade 1 or 2, 1% of grade 4) and neutropenia occurring in 12% of patients (3% of grade 1 or 2, 9% of grade 3 or higher). No treatment-related deaths were reported.

Number and title of the presentation
Abstract #623
Jurczak et al: Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL): Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study

Combination of MOR208 with lenalidomide and ibrutinib in CLL from phase 2 investigator-initiated trial

A second presentation is a poster from investigators at The Ohio State University, who reported on an investigator-initiated trial (IIT) evaluating MOR208 in combination with lenalidomide in three cohorts of patients with chronic lymphatic leukemia (CLL): previously untreated CLL patients, relapsed/refractory CLL patients; and patients with Richter’s Transformation.

The trial also included a 4th cohort of ibrutinib-treated CLL patients with identified resistance mutations to ibrutinib in the tumors (molecular relapse) but no confirmed clinical relapse where MOR208 was added to ibrutinib therapy. Recent data have generally shown poor clinical outcomes in patients who relapse after a therapy with the BTK inhibitor ibrutinib and whose leukemia cells carry a mutation in the BTK gene prior to relapse.

According to the data presented, 34 patients have been enrolled in the study so far, 27 receiving MOR208 in combination with lenalidomide (11 of which in the previously untreated cohort, 11 in the relapsed/refractory cohort, 5 in the Richter’s Transformation cohort) and 7 receiving MOR208 plus ibrutinib, with patient accrual still ongoing.

Most frequent hematological adverse event over all cohorts were thrombocytopenia in 47% of patients (9% grade 3 or higher) and neutropenia in 35% (21% grade 3 or higher). There were no unexpected serious adverse events reported.

According to the abstract, in the group of CLL patients with ibrutinib-resistant cells receiving MOR208 in addition to ibrutinib, four out of seven patients have been on study for at least 3 cycles of 28 days each already, and no patient had developed progressive disease at the time of abstract data cut-off. Preliminary activity has been seen in all cohorts, including ibrutinib-resistant CLL patients.

"There is a high unmet medical need for CLL patients, especially those showing resistance to ibrutinib therapy," said Dr. Jennifer Woyach, Assistant Professor of Internal Medicine at Ohio State University. "Therefore we added an additional cohort to our ongoing CLL study to evaluate MOR208 in combination with ibrutinib in order to investigate whether MOR208 could be a promising combination partner in this setting. We are looking forward to the continuation of the trial and to present further results going forward."

Number and title of the presentation
Abstract #4386
Woyach et al: Updated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter’s Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones

MorphoSys held an Investor & Analyst Event at the 2016 ASH (Free ASH Whitepaper) Annual Meeting on December 5, 2016, at 8:00pm PST (December 6, 2016: 4:00am GMT, 5:00am CET). Two clinical investigators presented clinical data for MorphoSys’s investigational agents MOR208 and MOR202.
A replay and the presentation will be made available at View Source
Webcast: View Source

On December 5, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported key presentations of clinical and scientific data related to its products at the San Antonio Breast Cancer Symposium (SABCS), being held in San Antonio, Texas, from December 6-10, 2016 (Press release, Spectrum Pharmaceuticals, DEC 5, 2016, View Source [SID1234516921]).

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For more information about the SABCS meeting and for a complete list of abstracts, please refer to the conference website at View Source

The following are key ROLONTISTM (eflapegrastim) related abstracts being presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-01-11 Poster
Randomized phase 3 study of a novel, long-acting G-CSF (eflapegrastim) versus pegfilgrastim in the management of chemotherapy-induced neutropenia in early-stage breast cancer patients receiving docetaxel and cyclophosphamide (TC) (ADVANCE study)

Schwartzberg Wednesday, Dec 7
5:00 PM
P5-11-09 Poster
Sustained efficacy of eflapegrastim in breast cancer patients in a phase 2, open-label, dose-ranging study

Vacirca Friday, Dec 9
5:00 PM
P5-11-07 Poster
Pharmacokinetics of eflapegrastim in a phase 2 open-label dose-ranging study in breast cancer patients receiving TC regimen

Vacirca Friday, Dec 9
5:00 PM
P5-11-08 Poster
Immunogenicity of eflapegrastim in a Phase 2 Open-Label Dose-Ranging Study of eflapegrastim in Breast Cancer Patients Receiving TC Regimen

Vacirca Friday, Dec 9
5:00 PM
The following key poziotinib related abstract will be presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-02-10 Poster
A phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) who have received prior HER2 regimens for MBC

Lathrop Wednesday, Dec 7
5:00 PM

On December 5, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported advances in precision oncology using the Prosigna Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) (Press release, NanoString Technologies, DEC 5, 2016, View Source [SID1234516969]). In addition, numerous customers will be presenting data generated using NanoString’s nCounter Analysis System, including several involving immuno-oncology.

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"The volume and impact of the clinical research being presented at the SABCS underscores our commitment to improving the lives of breast cancer patients," said Brad Gray, president and chief executive officer of NanoString Technologies. "These studies demonstrate that our Prosigna Assay can improve decision-making in early-stage breast cancer today, and that a modified companion diagnostic version of this assay has future potential in triple negative breast cancer. The studies also show that our nCounter Analysis System is continuing to grow in prominence as an important tool among breast cancer researchers."

NanoString and its collaborators will present three oral presentations and fourteen posters covering Prosigna/PAM50 and other nCounter-based research at SABCS, which is being held December 6-10, 2016.

Following are details for each presentation of data involving Prosigna and the PAM50 gene signature (all times are in Central Standard Time):

Wednesday, December 7, 2016

Abstract: P1-07-10
Poster: Prediction of 10 year distant recurrence (DR) using the Prosigna (PAM50) assay in histological subgroups of a Danish Breast Cancer Cooperative Group (DBCG) cohort of postmenopausal Danish women with hormone receptor-positive (HR+) early breast cancer (EBC) allocated to 5yr of endocrine therapy (ET) alone
Authors: Laenkholm A-V, Jensen M-B, Buckingham W, Schaper C, Knoop A, Eriksen JO, Rasmussen BB, Ferree S, Haffner T, Kiboel T, Ejlertsen B.
Location: Hall 1
Time: 5:00 – 7:00 p.m.

Abstract: P1-09-09
Poster: Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer
Authors: Prat A, Ortega V, Villagrasa P, Paré L, Galván P, Oliveira M, Nucíforo P, Lluch A, Morales S, Amillano K, Lopez R, Gonzalez R, Manso L, Martinez J, Llombart A, De la Peňa L, Di Cosimo S, Rubio IT, Harbeck N, Baselga J, Cortés J
Location: Hall 1
Time: 5:00 – 7:00 p.m.
Thursday, December 8, 2016

Abstract: P2-05-04
Poster: Evaluation of intra-tumor heterogeneity, test reproducibility and their impact in breast cancer samples assessed by Prosigna: results from a Decision Impact prospective study and a matched case-control study
Authors: Rouzier R, Bonneau C, Cayre A, Hequet D, Gentien D, Bonhomme A, Mouret-Reynier M-A, Dubot C, Cottu P, Roulot A, Morel P, Salomon A, Callens C, Guinebretiere J-M, Penault-Llorca F
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-03-03
Poster: Molecular differences between screen-detected and interval breast cancers are largely explained by PAM50 subtypes
Authors: Czene K, Ivansson E, Klevebring D, Tobin NP, Lindström LS, Holm J, Prochazka G, Hilliges C, Palmgren J, Törnberg S, Humphreys K, Hartman J, Frisell J, Rantalainen M, Lindberg J, Hall P, Bergh J, Grönberg H, Li J
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-05-16
Poster: Establishment of molecular profiling for individual treatment decisions in early breast cancer – clinical impact of PAM50 and PAM50 risk of recurrence score after more than 16 years follow up.
Authors: Naume B, Borgen E, Falk RS, Ohnstad HO, Lien TG, Aaserud M, Sveli MAT, Kyte JA, Kristensen V, Geitvik G, Schlichting E, Wist E, Sørlie T, Russnes H
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S3-03
Oral Session: General Session 3
Poster: PAM50 intrinsic subtype as a predictor of pathological complete response following neoadjuvant dual HER2 blockade without chemotherapy in HER2-positive breast cancer: First results of the PAMELA clinical trial
Authors: Prat Aparicio A, Cortes Castan J, Pare L, Galvan P, Bermejo B, Martínez N, Vidal M, Pernas S, Lόpez R, Muñoz M, Nuciforo P, Fasani R, Morales S, Oliveira M, de La Peña L, Peláez A, Llombart A
Location: Hall 3
Time: 10:00 a.m.
Friday, December 9, 2016

Abstract: S6-05
Oral Session: General Session 6: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC
Authors: Sestak I, Buus R, Cuzick J, Dubsky P, Kronenwett R, Ferree S, Sgroi D, Schnabel C, Baehner R, Mallon E, Dowsett M.
Location: Hall 3
Time: 4:15 p.m.
Saturday, December 10, 2016

Abstract: P6-07-01
Poster: Development of a Prosigna (PAM50)-based classifier for the selection of advanced triple negative breast cancer (TNBC) patients for treatment with enzalutamide
Authors: Danaher P, Skewis L, Mashadi-Hossein A, Carey C, Ram N, Gowen-MacDonald J, Harris E, Cesano A, Ferree S, Uppal H, Buckingham W.
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Additional abstracts and posters demonstrate the diverse applications and robust performance of the nCounter Analysis System in immuno-oncology and biomarker validation, including:

Wednesday, December 7, 2016

Abstract: P1-05-22
Poster: The value of RNA-Seq for the detection of clinically actionable targets in breast cancer – A small cohort analysis
Authors: Meissner T, Amallraja A, Mark A, Andrews A, Connolly C, Young B, De P, Williams C, Leyland-Jones B
Location: Hall 1
Time: 5:00 p.m.
Thursday, December 8, 2016

Abstract: P2-04-07
Poster: Immune profiling of post neoadjuvant high metastatic risk (RCB-II/III) residual disease in patients with early triple negative breast cancers
Authors: Irshad S, Cheang M, Gazinka P, Naidoo K, Buus R, Pinder S, Dowsett M, Tutt A
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-04-19
Poster: Elucidating the tumor immune microenvironment phenotype in early stage untreated BRCA mutated breast cancer patients
Authors: Force J, Abbott S, Broadwater G, Kimmick G, Westbrook K, Hwang S, Kauff N, Stashko I, Weinhold K, Nair S, Hyslop T, Blackwell K, Castellar E, Marcom PK
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S4-01
Oral Session: General Session: A novel BRD4 inhibitor enhances endocrine therapy efficacy and circumvents endocrine-resistance in estrogen receptor-positive breast cancer models
Authors: De Angelis C, Nardone A, Cataldo ML, Fu X, Trivedi M, Yi S, Breckenridge D, Chamnsess GC, Vitorino P, Osborne CK, Schiff R
Location: Hall 3
Time: 3:15 – 5:00 p.m.

Abstract: PD5-06
Poster: Prognostic value of molecular tumor infiltrating lymphocyte (mTIL) signatures in HER2-positive breast cancer patients in N9831 and FinHer/FinXX trials
Authors: Chumsri S, Serie DJ, Mashadi-Hossein A, Tenner KS, Lauttia SL, Moreno-Aspitia A, McLaughlin SA, Nassar A, Warren S, Danaher P, Colon-Otero G, Lindman H, Joensuu H, Perez EA, Thompson EA
Location: Stars at Night Ballroom 1&2 – 3rd Level
Time: 5:00 – 7:00 p.m.
Friday, December 9, 2016

Abstract: P4-07-06
Poster: MicroRNAs associated with acquired taxane resistance in a breast cancer cell line model
Authors: Taylor KJ, Chong T, D’Costa A, Yao C, Gourley C, Cameron DA, Bartlett JMS, Spears M
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P4-12-09
Poster: The immune response in triple negative breast cancer
Authors: Gillgrass AE, Pond GR, Levine MN, Whelan TJ, Hassell JA, Bane AL
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Saturday, December 10, 2016

Abstract: P6-07-07
Poster: ESR1 amplification and 5′-3′ exon imbalance in metastatic breast cancer
Authors: Oesterreich S, Basudan A, Preideigkeit N, Hartmaier RJ, Bahreini A, Gyanchandani R, Leone JP, Lucas PC, Hamilton RL, Brufsky AM, Lee AV
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P6-09-47
Poster: The development of personalized diagnostic tests and therapeutic strategies in breast cancer
Authors: Kutasovic JR, Rozali E, Miranda M, Lakhani SR, Al-Ejeh F
Location: Hall 1
Time: 7:30 – 9:00 a.m.
You can learn more about the Prosigna Breast Cancer Gene Signature at booth #525.

On December 5, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), a rare cancer-focused innovative biotechnology company, reported clinical data on brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the ongoing Phase 1/2 and pivotal ALTA trials in patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC) and intracranial central nervous system (CNS) metastases (Press release, Ariad, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227425 [SID1234516925]). These data, being presented today at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer (WCLC) being held in Vienna, showed that in patients with measurable brain metastases, the confirmed intracranial objective response rate (ORR) was 53 percent in the Phase 1/2 trial, and the confirmed intracranial ORR was 67 percent in Arm B (brigatinib 180 mg with seven-day lead-in at 90 mg once daily) in the ALTA trial. Median intracranial progression-free survival (PFS) in ALTA Arm B was 18.4 months.

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"Although crizotinib is initially effective in most patients with advanced ALK rearranged lung cancer, patients eventually develop resistance to crizotinib, often with new or progressive brain metastases," said presenting author Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer Center. "We are clearly encouraged by these data that demonstrate efficacy in the brain, with median intracranial PFS of over one and a half years, in patients with crizotinib refractory disease."

The ALTA Trial

The ALTA (ALK in Lung Cancer Trial of AP26113) trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on their most recent crizotinib therapy. 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 presence of brain metastases at baseline and best response to prior crizotinib therapy. Patient enrollment is complete, with the last patient enrolled in September 2015. Median follow-up in all patients with intracranial CNS metastases at baseline enrolled in the ALTA trial was 10.7 months as of May 31, 2016.

Phase 1/2 Study

The Phase 1/2 study of brigatinib included a dose-escalation portion that enrolled patients with advanced solid tumors, particularly those with NSCLC, who were either refractory to available therapies or had no standard treatment available to them. The Phase 2 portion of the trial includes five expansion cohorts. The trial enrolled 137 patients with 79 patients having ALK+ NSCLC. All but eight ALK+ NSCLC patients had failed prior crizotinib therapy. Patient enrollment in the trial is complete, with the last patient enrolled in July 2014. Median follow-up in ALK+ NSCLC patients with intracranial CNS metastases at baseline in the Phase 1/2 study was 24.9 months as of May 31, 2016.

Key Data from Oral Presentation on Patients with Baseline CNS Metastases from Phase 1/2 and ALTA Trials

Follow-up Data as of May 31, 2016; Last IRC Data in ALTA Trial was July 13, 2016, and Last Brain Scan in Phase 1/2 Trial was October 8, 2015

In the Phase 1/2 trial of brigatinib, 50/79 (63%) of ALK+ NSCLC patients had IRC-assessed baseline brain metastases. In the ALTA trial, 153/222 (69%) of ALK+ NSCLC patients had IRC-assessed baseline brain metastases. The efficacy analysis of Phase 1/2 trial data was based on an evaluable population (patients with at least one on-study brain scan, n=46), and the analysis of ALTA trial data was based on the intention-to-treat (ITT) population (n=153).
As of May 31, 2016, 42 percent and 55 percent of ALK+ NSCLC patients with brain metastases at baseline remained on study in the Phase 1/2 and ALTA populations respectively.
For patients with measurable brain lesions, the confirmed intracranial ORR was 53 percent (8/15) in the Phase 1/2 trial, and confirmed intracranial ORRs were 67 percent (12/18) in Arm B and 46 percent (12/26) in Arm A in the ALTA trial.
There were 31 patients in the Phase 1/2 trial with only non-measurable brain lesions, and of these, 35 percent had complete resolution of lesions. In ALTA, there were 55 patients in Arm B and 54 in Arm A with only non-measurable lesions; of these, 18 percent and seven percent of patients, respectively, had complete resolution of lesions.
For patients with any brain metastases at baseline:
Median duration of intracranial response in confirmed responders was 11.4 months in the Phase 1/2 trial (n=19); and was not yet reached in either arm of the ALTA trial (n=22 in Arm B and n=16 in Arm A).
Median intracranial PFS was 14.6 months in the Phase 1/2 trial (n=46); and 18.4 months (95% confidence interval [CI] 12.8 – not reached) and 15.6 months (95% CI 9.0-18.3 months) in ALTA Arm B and Arm A, respectively (n=73/n=80).
In the Phase 1/2 trial (n=46), for patients with any brain metastases at baseline, investigator-assessed whole-body ORR was 74 percent, median duration of response was 24 months and median PFS was 14.5 months. In ALTA (Arms B and A, respectively), for patients with any brain metastases at baseline, investigator-assessed whole-body ORR was 58 percent and 39 percent, median duration of response was not yet reached and 12 months, and median PFS was 12.9 months and 9.2 months.
In patients with any brain metastases at baseline in the ALTA trial, the most common treatment-emergent adverse events (AEs), grade 3 or higher (excluding neoplasm progression), were (n=151 treated; Arm B/A): increased creatine phosphokinase (CPK) (12%/1%), hypertension (7%/4%), increased lipase (3%/4%), malignant pleural effusion (1%/4%) and pneumonia (4%/1%).
The oral presentation, "Brigatinib Activity in Patients with ALK+ NSCLC and Intracranial CNS Metastases in Two Clinical Trials," (Abstract #4374, Oral ID OA08.06) will be presented today, Monday, December 5, 2016 in the Schubert 1 Auditorium at 11:57 am ET/16:57 GMT.

Investor and Analyst Briefing and Webcast

Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD will host an investor and analyst briefing on Wednesday, December 7 at 4:00 p.m. Central European Time (10:00 a.m. Eastern Time) to discuss the data presented at WCLC. Dr. Clackson will be joined by Karen Reckamp, M.D., associate professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope Comprehensive Cancer Center (COHCCC).

The live webcast can be accessed by visiting the investor relations section of the Company’s website at View Source The call can be accessed by dialing 844-249-9386 (domestic) or 270-823-1534 (international) five minutes prior to the start time and providing the pass code 20888507. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. The FDA has accepted brigatinib’s New Drug Application based on data from an earlier datacut, and has granted ARIAD’s request for Priority Review. The FDA has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA). ARIAD intends to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017, based on this datacut.

ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy and safety of brigatinib in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor. More information on brigatinib clinical trials, as well as the expanded access program (EAP) for ALK+ NSCLC can be found here.