On June 3, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and QIAGEN (NASDAQ:QGEN; Frankfurt Prime Standard:QIA) reported that they have signed an agreement to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with Bristol-Myers Squibb novel immuno-oncology (I-O) therapies in cancer treatment (Press release, Bristol-Myers Squibb, JUN 3, 2017, View Source [SID1234519383]). This will leverage the combination of Bristol-Myers Squibb’s portfolio of I-O therapies with QIAGEN’s proven track record in developing and commercializing companion and complementary diagnostics as well as QIAGEN’s portfolio of NGS technologies. I-O therapies offer a novel way to treat cancer by using drugs to target the body’s immune system to help fight cancer.

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QIAGEN and Bristol-Myers Squibb intend to develop GEPs for several Bristol-Myers Squibb I-O molecules under the initial agreement. The companies also plan to enter into a further agreement to develop diagnostic products using the jointly developed GEPs and to expand the use of NGS technology with other Bristol-Myers Squibb I-O therapies.

"Greater precision in the treatment of cancer may enable faster decision making to identify which patient populations are most likely to derive benefit from our immuno-oncology agents," said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. "We believe working with QIAGEN will help develop better diagnostic tools to target the most appropriate immunotherapies across a number of different tumor types."

"We are very pleased to work with Bristol-Myers Squibb to potentially create what could be the first-ever NGS-based companion or complementary diagnostic to provide key insights for personalized decision-making in the rapidly expanding area of immuno-oncology," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "Our teams at QIAGEN are looking forward to working with Bristol-Myers Squibb to leverage the power of NGS technology to potentially improve outcomes for patients."

QIAGEN and Bristol-Myers Squibb have been partnering since 2009. A key milestone in this partnership was the FDA approval of the Therascreen KRAS companion/complementary diagnostic assay in 2012.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ individual tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

QIAGEN GeneReader NGS System

The GeneReader NGS System provides the first true Sample to Insight NGS workflow for laboratories worldwide – and increasingly also pharmaceutical companies – to take advantage of the power of NGS technology. The system’s integrated bioinformatics for analysis and interpretation of NGS data, as well as a family of gene panels under the GeneRead QIAact brand, enable laboratories to identify gene variations linked to cancers and to deliver actionable molecular insights. The capabilities of this unique system also include high-sensitivity detection in liquid biopsy samples, compatibility with the QIAsymphony automation platform for high-throughput sample processing, and software integration with leading Laboratory Information Management Systems (LIMS). The current version of the GeneReader NGS System is available in the United States for research use only.

On June 3, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported the online publication of a new research brief in Cancer Discovery outlining the preclinical rationale for LOXO-195 and clinical proof-of-concept data from the first two patients treated (Press release, Loxo Oncology, JUN 3, 2017, View Source [SID1234519387]). LOXO-195 was developed to treat patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as Loxo Oncology’s larotrectinib.

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"This publication highlights the potential for LOXO-195 to extend the period of durable disease control for patients with TRK fusion cancers," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We believe that today’s ASCO (Free ASCO Whitepaper) presentation establishes larotrectinib as the clear first choice for patients with TRK fusion cancers. However, over time, patients will require new treatment options, since oncogene-addicted metastatic cancers ultimately evade targeted therapies. We have been relentless in the development of LOXO-195 so that it could be ready in time for the current larotrectinib clinical trial participants and future patients who depend upon us to realize the full potential of TRK inhibition in the management of advanced cancer."

LOXO-195 was designed to address anticipated mechanisms of acquired resistance in cancers exposed to a prior TRK inhibitor, including "solvent front" mutations (e.g. NTRK1 G595R, NTRK3 G623R), which are not well-addressed by existing investigational agents. LOXO-195 will be developed as a sequential treatment, to follow larotrectinib or another TRK inhibitor, to extend the total time of benefit from TRK inhibition.

The Cancer Discovery research brief provides early but encouraging evidence that the sequential use of larotrectinib followed by LOXO-195 could extend the total duration of disease control for patients with TRK fusion cancers. An analogous paradigm has already been established for other oncogene-addicted tumors, such as those driven by androgen and estrogen signaling, EGFR mutations and ABL gene fusions. The brief describes the first two patients with TRK fusion cancers who responded to larotrectinib but later relapsed. An adult with colorectal cancer and a child with infantile fibrosarcoma were biopsied at the time of tumor progression and found to have a solvent front TRK mutation in the existing TRK fusion, which explained the diminished activity of larotrectinib. As no other treatment options exist to address TRK fusion solvent front mutations, Loxo Oncology, in collaboration with the U.S. FDA, enabled these patients to access LOXO-195 through emergency use Investigational New Drug applications (INDs). Both patients responded to LOXO-195, with minimal adverse events reported.

A formal LOXO-195 IND was recently cleared by the U.S. FDA, and a Phase 1/2 trial is opening globally.

About LOXO-195
LOXO-195 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that have acquired resistance to initial TRK therapy such as larotrectinib. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Though drugs such as larotrectinib can induce durable responses in these patients, the cancer may eventually begin to grow again. This phenomenon is called "acquired resistance," in that the cancer has acquired features conferring resistance to the initial therapy that was once effective. Emerging data in the field of TRK inhibition suggest that acquired resistance may emerge due to TRK kinase point mutations, such as those in the solvent front domain, xDFG domain, or gatekeeper region. LOXO-195 was designed to address these new point mutations and induce a new response in the patient’s cancer. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or email [email protected].

About TRK Fusion Cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.

On June 3, 2017 Pfizer Inc. (NYSE:PFE) reported Phase 2 data showing that its investigational, dual-mechanism poly ADP ribose polymerase (PARP) inhibitor, talazoparib, demonstrated anti-tumor activity in patients with germline (inherited) BRCA1/2-positive (gBRCA+) advanced breast cancer (Press release, Pfizer, JUN 3, 2017, View Source [SID1234519408]). Results from the Phase 2 ABRAZO trial were presented during an oral session at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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"Every day, I see the devastating effects of gBRCA+ advanced breast cancer – one of the most common forms of inherited breast cancer," said Nicholas C. Turner, MD, PhD, consultant medical oncologist at the Royal Marsden Hospital in London, United Kingdom. "As we learn more about the genetic drivers of cancer, mechanisms such as PARP inhibition are emerging as a potential therapeutic approach for this patient population."

ABRAZO is an open-label Phase 2, 2-stage, single arm, parallel cohort study that investigated the clinical efficacy and safety of single-agent talazoparib in 83 evaluable, heavily pretreated gBRCA+ advanced breast cancer patients. The primary endpoint was objective response rate (ORR) by independent radiology review.

Cohort 1 consisted of 49 patients who previously responded to platinum-based chemotherapy and subsequently developed disease progression. A 21% ORR (95% CI: 10-35) was observed in this group of patients. Cohort 2 consisted of 35 patients who developed disease progression following at least three lines of non-platinum-based therapy. This group of patients had a 37% ORR (95% CI: 22-55).

The most common adverse events (AEs) observed in at least 20% of patients consisted of anemia (51.8%), thrombocytopenia (32.5%), neutropenia (26.5%), fatigue (44.6%), nausea (42.2%), diarrhea (32.5%), decreased appetite (24.1%), dyspnea (24.1%), alopecia (21.7%), back pain (21.7%) and vomiting (20.5%). Grade 3 or 4 AEs observed in at least 10% of patients were anemia (34.9%), thrombocytopenia (19.3%) and neutropenia (14.5%). Hematological AEs were addressed with dose management. No clinically significant cardiovascular events were observed. Discontinuation rates due to drug-related AEs were low (4%).

"The activity observed in patients with gBRCA+ advanced breast cancer in the ABRAZO trial is highly encouraging. The Phase 3 EMBRACA trial was designed to build upon these results to determine whether talazoparib represents a potential treatment option in this type of breast cancer," said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development.

Talazoparib is also being assessed in the open-label Phase 3 randomized, parallel, 2-arm EMBRACA trial. EMBRACA is evaluating talazoparib vs. protocol-specific physician’s choice of chemotherapy in patients with advanced and/or metastatic gBRCA+ breast cancer who have received zero to three prior chemotherapy regimens for advanced disease. The EMBRACA trial has completed enrollment and results will be made available at a future date.

About the ABRAZO Trial

Patients enrolled in the multicenter, open-label Phase 2, 2-stage, parallel cohort study received talazoparib once daily for 21 days in repeated 21-day cycles. Patients had triple negative breast cancer, hormone receptor-positive (HR+) breast cancer, or human epidermal growth factor 2 (HER2)-positive breast cancer that was refractory to HER2-targeted therapy. The median number of prior lines of chemotherapy for advanced breast cancer was two in Cohort 1 and four in Cohort 2. Investigators required at least five objective responses per cohort in ≤35 patients to progress from the first stage of the trial to the second stage. Both cohorts met the response criteria for advancement.

About Talazoparib

Talazoparib is an investigational anticancer compound called a PARP (poly ADP ribose polymerase) inhibitor, which is being evaluated in gBRCA+ breast cancer, as well as other cancer types with deficiencies in DNA damage repair (DDR). Preclinical studies suggest that talazoparib has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

About Germline BRCA1/2-Positive Breast Cancer

BRCA1 and BRCA2 are human genes that produce proteins involved in DNA repair. When either of these genes is altered or mutated, DNA repair may not progress correctly. This can lead to the development of certain types of cancer – such as breast cancer.1,2,3 BRCA mutations can be hereditary (germline) or occur spontaneously (sporadic).1 BRCA mutations are the most common cause of hereditary breast cancers, and up to 65% of women who inherit a BRCA mutation will develop breast cancer by age 70.1,4 Epidemiologic studies indicate that individuals with gBRCA+ status are diagnosed with breast cancer at a median age of 40-45, which is approximately 20 years younger than the overall breast cancer population.5 Literature indicates that 5-10% of all breast cancer patients have a gBRCA mutation.6

On June 3, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the presentation of positive results from an ongoing Phase II clinical trial (Translational Breast Cancer Research Consortium TBCRC 022) of Puma’s investigational drug PB272 (neratinib) for the treatment of HER2-positive metastatic breast cancer that has metastasized to the brain (Press release, Puma Biotechnology, JUN 3, 2017, View Source [SID1234519409]). The data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting in Chicago, Illinois.

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The multicenter Phase II clinical trial enrolled patients with HER2-positive metastatic breast cancer who have brain metastases. The trial is being performed by the TBCRC and enrolled three cohorts of patients. Patients in the first cohort (n=40) included those with progressive brain metastases who were administered neratinib monotherapy. Data from this cohort were previously reported at the 2014 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the Journal of Clinical Oncology in 2016. Patients in the second cohort (n=5) represent patients who had brain metastases which were amenable to surgery and who were administered neratinib monotherapy prior to and after surgical resection. The third cohort (target enrollment=60) enrolled two sub-groups of patients (prior lapatinib-treated and no prior lapatinib) with progressive brain metastases who were administered neratinib in combination with the chemotherapy drug capecitabine. The oral presentation reflects only the patients in the third cohort of patients without prior lapatinib exposure (cohort 3A, n=37), who all had progressive brain metastases at the time of enrollment and who received the combination of capecitabine plus neratinib. A full copy of the oral presentation that was presented at the ASCO (Free ASCO Whitepaper) Annual Meeting is available on the Puma Biotechnology website. Results from the second cohort and cohort 3B (prior lapatinib-treated) will be presented at a forthcoming medical meeting.

In cohort 3A, 30% of the patients had received prior craniotomy, 65% of the patients had received prior whole brain radiotherapy (WBRT), and 35% had received prior stereotactic radiosurgery (SRS) to the brain. No patients had received prior treatment with lapatinib.

The primary endpoint of the trial was central nervous system (CNS) Objective Response Rate according to a composite criteria that included volumetric brain MRI measurements, steroid use, neurological signs and symptoms, and RECIST evaluation for non-CNS sites. The secondary endpoint of the trial was CNS response by Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria. The efficacy results from the trial showed that 49% of patients experienced a CNS Objective Response by the composite criteria. The results also showed that the CNS response rate using the RANO-BM criteria was 24%. The median time to CNS progression was 5.5 months and the median overall survival was 13.5 months, though 49% of patients remain alive and survival data are immature.

The results for cohort 3A showed that the most frequently observed severe adverse event for the 37 patients evaluable for safety was diarrhea. Patients received antidiarrheal prophylaxis consisting of high dose loperamide, given together with the combination of capecitabine plus neratinib for the first cycle of treatment in order to try to reduce the neratinib-related diarrhea. Among the 37 patients evaluable for safety, 32% of the patients had grade 3 diarrhea and 41% had grade 2 diarrhea.

"Neratinib given in combination with capecitabine showed promising activity in patients with heavily pre-treated HER2-positive disease metastatic to the CNS," said Rachel A. Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute. "Despite the introduction of several new treatments for patients with HER2-positive metastatic breast cancer, CNS progression events remain a major source of patient morbidity and mortality. Based on the results from TBCRC-022, we look forward to additional trials with neratinib-based regimens for HER2-positive CNS disease."

"We are very pleased with the activity seen in this trial with the combination of neratinib plus capecitabine," said Alan H. Auerbach, CEO and President of Puma Biotechnology. "As a small molecule that can cross the blood brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option. We look forward to working with TBCRC on future trials of neratinib in patients with HER2-positive disease metastatic to the CNS."

On June 3, 2017 Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported interim clinical data from all three ongoing larotrectinib (LOXO-101) clinical trials in patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions (Press release, Loxo Oncology, JUN 3, 2017, https://ir.loxooncology.com/press-releases/loxo-oncology-breakthrough-therapy-larotrectinib-demonstrates-76-percent-confirmed-objective-response-rate-in-trk-fusion-adult-and-pediatric-cancers-as-presented-at-the-american-society-of-clinical-on [SID1234519411]). These data, demonstrating a 76 percent confirmed objective response rate (ORR) across tumor types, are being presented today at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (abstract LBA2501). The larotrectinib pediatric data, included in this presentation, are also being presented in a separate oral presentation on Monday, June 5th (abstract 10510).

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"Larotrectinib delivers consistent and durable responses in TRK fusion patients across all ages, regardless of tumor context, and does so with few side effects," said David Hyman, M.D., the NAVIGATE global principal investigator and chief of the early drug development service at Memorial Sloan Kettering Cancer Center who will present the data at ASCO (Free ASCO Whitepaper). "In this way, the larotrectinib TRK fusion story fulfills the promise of precision medicine, where tumor genetics rather than tumor site of origin define the treatment approach. It is now incumbent upon the clinical oncology and pathology communities to examine our testing paradigms, so that TRK fusions and other actionable biomarkers become part of the standard patient workup."

The ASCO (Free ASCO Whitepaper) presentation includes adult and pediatric patients with RECIST-evaluable TRK fusion cancers enrolled across all three larotrectinib clinical trials, and employs an April 14, 2017 data cut-off. These patients will serve as the basis for the larotrectinib New Drug Application (NDA), which the company expects to submit in late 2017 or early 2018 for evaluation by the U.S. Food and Drug Administration (FDA). The primary analysis for the NDA will rely upon central, independent radiology review, which will be performed in the second half of 2017. The company plans to announce these data, which will also include additional patient follow-up, before the end of 2017.

Larotrectinib received Breakthrough Therapy Designation from the FDA in July 2016, "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments."

"The Loxo Oncology team is proud to have contributed to these important data presentations at ASCO (Free ASCO Whitepaper)," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We are grateful to the patients, families, and clinical trial teams who help push the boundaries of available care through their participation in clinical trials. We hope that larotrectinib is the first of many new medicines we develop together."

Key Data Presented at ASCO (Free ASCO Whitepaper)
The primary efficacy outcome measure for the analysis presented at ASCO (Free ASCO Whitepaper) is objective response rate (ORR) as measured by RECIST v 1.1. Key secondary endpoints include duration of response (DOR), progression-free survival (PFS) and safety. The data presented at ASCO (Free ASCO Whitepaper), summarized below, are based on response assessments as performed by each respective clinical trial site (local, investigator-assessed radiology). A separate response assessment performed by independent radiologists, not yet conducted, will be required to support global regulatory filings.

Consistent with written FDA correspondence, TRK fusion patients enrolled in Loxo Oncology’s Phase 1 adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric trial (SCOUT) contributed to the primary efficacy analysis. The data presented are based on the intent to treat (ITT) principle, using the first 55 TRK fusion patients with RECIST-evaluable disease enrolled to the three clinical trials, regardless of prior therapy or tumor tissue diagnostic method.

Forty-three adult and 12 pediatric patients were enrolled, identified by 15 different lab tests. TRK fusion patients carried primary diagnoses of appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal stromal tumor (GIST), infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. One patient had central nervous system (CNS) metastases at study entry.

Enrolled Patients with Confirmatory Response Data Available (n=50) All Enrolled Patients (n=55)*
Objective Response Rate
(ORR = PR+CR) 76%
(95% CI: 62% – 87%) 78%
(95% CI: 65% – 88%)
Partial Response (PR) 64% 65%*
Complete Response (CR) 12% 13%*
Stable Disease 12% 11%
Progressive Disease 12% 11%
* Includes unconfirmed responses with confirmatory scans pending (4 PR, 1 CR). All patients with unconfirmed responses remain in response and ongoing on study.

As shown in the above table, the confirmed ORR is 76 percent in 50 patients for whom follow-up was sufficiently long to include a confirmatory scan. The ORR is 78 percent when an additional 5 patients, recently enrolled, with unconfirmed PR (n=4) and CR (n=1), are included. ORR was generally consistent across tumor types, TRK gene fusions, and various diagnostic tests. In the pediatric setting, larotrectinib showed promising activity in the pre-surgical management of patients with infantile fibrosarcoma, with 3 patients treated to best response, which allowed for subsequent referral to surgery with curative intent.

Median DOR and PFS have not been reached. Ninety-three percent of all responding patients either remain on drug or received surgery with curative intent. Seventy-five percent of all patients enrolled either remain on drug or received surgery with curative intent.

The safety data presented at ASCO (Free ASCO Whitepaper) encompass the entire larotrectinib safety database in cancer patients (n=125) intended to support an NDA. The most common treatment-emergent adverse events, regardless of relationship to larotrectinib, included fatigue (15% Grade 1, 18% Grade 2, 5% Grade 3), dizziness (22% Grade 1, 4% Grade 2, 2% Grade 3), nausea (20% Grade 1, 5% Grade 2, 2% Grade 3), and anemia (8% Grade 1, 9% Grade 2, 9% Grade 3). Seven (13%) of patients required a dose reduction due to an adverse event. Of note, all patients requiring dose reduction experienced tumor regression (1 CR, 5 PR, 1 SD), which has continued on the reduced dose. Nearly all of the dose reductions were due to infrequent neurocognitive adverse events, likely a result of on-target TRK inhibition in the CNS. No patients discontinued larotrectinib due to an adverse event.

Six patients responded to larotrectinib but subsequently progressed, a pattern referred to as "acquired resistance." Progression biopsies from five of six patients indicate a consistent mechanism of acquired resistance, namely a solvent front mutation. A solvent front mutation is an amino acid substitution in a kinase that reduces the binding potency of a targeted drug. In the case of NTRK1 and NTRK3, these solvent front amino acid substitutions are denoted as G595R and G623R, respectively. The presence of an acquired resistance mutation in a primary activating oncogene suggests that the involved cancer cell remains dependent on the aberrant signaling pathway that had been successfully drugged previously. LOXO-195, Loxo Oncology’s next-generation selective TRK inhibitor, was designed to address solvent front and other acquired resistance mutations to potentially induce new responses in TRK fusion dependent cancers with acquired resistance mutations.

About the ASCO (Free ASCO Whitepaper) Presentations
These data are being presented in two oral presentations at ASCO (Free ASCO Whitepaper).

"The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers." This includes the integrated database across the three larotrectinib clinical trials and is being presented by Dr. David Hyman, Memorial Sloan Kettering Cancer Center, during the Session entitled, "Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics," from 1:15 – 4:15PM CT on Saturday, June, 3, 2017 (Abstract LBA2501).
"A pediatric phase 1 study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family." This focuses specifically on the pediatric Phase 1 clinical trial data, included in the aforementioned data set, and is being presented by Dr. Theodore Laetsch, University of Texas Southwestern Medical Center, during the Session entitled, "Pediatric Oncology II," from 8:00 – 11:00AM CT on Monday, June, 5, 2017 (Abstract 10510).
The presentations will be available online at View Source at the time of their scheduled presentation at ASCO (Free ASCO Whitepaper).

Conference Call and Webcast Information
Loxo Oncology will host a conference call and live webcast with slides and Q&A on Sunday, June 4, 2017 at 5:30 p.m. CT to discuss the larotrectinib data. Loxo Oncology management will be joined by the primary investigators of the larotrectinib clinical development program, Dr. David Hyman and Dr. Alex Drilon of Memorial Sloan Kettering Cancer Center, and Dr. Theodore Laetsch of University of Texas Southwestern Medical Center. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 14447513. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 90 days following the call.

About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated a 76 percent confirmed objective response rate (ORR), across many different types of solid tumors. Larotrectinib has been granted Breakthrough Therapy Designation Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.