On September 25, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Cantor Fitzgerald Global Healthcare Conference taking place October 1-3 in New York, NY (Press release, Exelixis, SEP 25, 2018, View Source;p=irol-newsArticle&ID=2368910 [SID1234529596]). The Exelixis presentation is scheduled for 9:10 AM EDT / 6:10 AM PDT on Tuesday, October 2, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On September 25, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sanky) reported that the first patients have been dosed in DESTINY-Breast03 and DESTINY-Breast02, two global phase 3 studies evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with previously-treated HER2 positive unresectable and/or metastatic breast cancer (Press release, Daiichi Sankyo, SEP 25, 2018, View Source [SID1234529580]). DESTINY-Breast03 will be a head-to-head comparison of [fam-] trastuzumab deruxtecan versus ado-trastuzumab emtansine (T-DM1), also a HER2 targeting ADC, while DESTINY-Breast02 will assess [fam-] trastuzumab deruxtecan in patients previously treated with standard of care HER2 therapies including T-DM1.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Current treatment guidelines for patients with HER2 positive metastatic breast cancer recommend the combination of trastuzumab, pertuzumab and a taxane as first-line therapy.1,2 For patients whose cancer progresses after initial treatment, T-DM1 is an anti-HER2 agent specifically approved for second-line therapy.1 For cancers that progress after HER2 targeted agents trastuzumab, pertuzumab and T-DM1, there is no specific standard of care. Options for these patients are standard chemotherapy with or without continued anti-HER2 therapy and consideration of palliative care.1

"The DESTINY-Breast03 trial is a key element of our comprehensive development strategy to determine the potential of [fam-] trastuzumab deruxtecan as a second-line therapy in patients with HER2 positive metastatic breast cancer," said Gilles Gallant, BPharm, PhD, Vice President, DS-8201 Global Team Leader, Oncology Research and Development, Daiichi Sankyo. "DESTINY-Breast03 will also help assess whether our investigational and proprietary ADC linker and payload technology used in [fam-] trastuzumab deruxtecan demonstrates clinical relevance when compared to another HER2 targeting ADC currently approved in this setting."

Enrollment into DESTINY-Breast01, the pivotal phase 2 trial evaluating [fam-] trastuzumab deruxtecan in HER2 positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 was completed in September 2018, with approximately 230 patients at more than 100 sites in North America, Europe, Japan and other countries in Asia.

About DESTINY-Breast03

DESTINY-Breast03 is a randomized, active-controlled, open-label, multicenter, two-arm, global phase 3 trial designed to compare the safety and efficacy of [fam-] trastuzumab deruxtecan versus T-DM1 in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival based on blinded independent central review. Secondary efficacy endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and progression-free survival based on investigator assessment. Safety endpoints include serious adverse events, treatment-emergent adverse events and adverse events of special interest. Exploratory efficacy endpoints include duration of stable disease and time to response. Health economics and outcomes research endpoints as well as pharmacokinetic and biomarker endpoints will also be measured.

DESTINY-Breast03 will enroll approximately 500 patients at 150 study sites in North America, Asia and Europe. For more information about the study, visit ClinicalTrials.gov.

About DESTINY-Breast02

DESTINY-Breast02 is a randomized, active-controlled, open-label, multicenter, two-arm, global phase 3 trial designed to compare the safety and efficacy of [fam-] trastuzumab deruxtecan versus investigator’s choice (trastuzumab plus capecitabine or lapatinib plus capecitabine) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with standard of care HER2 therapies including T-DM1.

The primary efficacy endpoint of DESTINY-Breast02 is progression-free survival based on blinded independent central review. Secondary efficacy endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and progression-free survival based on investigator assessment. Safety endpoints include serious adverse events, treatment-emergent adverse events and adverse events of special interest. Health economics and outcomes research endpoints as well as pharmacokinetic and biomarker endpoints will also be measured.

DESTINY-Breast02 will enroll up to 600 patients at approximately 160 study sites in North America, South America, Europe and Asia. For more information about the study, visit ClinicalTrials.gov.

About DESTINY-Breast01

DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part study evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with T-DM1.

The primary endpoint of the study is objective response rate. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. The first part of the study includes a pharmacokinetic stage and a dose finding stage to identify the recommended dose of [fam-] trastuzumab deruxtecan to be evaluated in the second part of the study. The second part of the study enrolled patients into one of two cohorts: patients resistant or refractory to T-DM1 (part 2a) and patients who discontinued treatment with T-DM1 for reasons other than resistant or refractory disease (part 2b). For more information about this study, visit ClinicalTrials.gov.

Unmet Need in HER2 Positive Metastatic Breast Cancer

Breast cancer is the second most common cancer worldwide, responsible for approximately 1.67 million of 14.1 million new cases of cancer diagnosed each year.4 Despite improving survival rates over the past 25 years, breast cancer was the fifth leading cause of cancer death overall and was the number one cause of cancer death in women in 2012.3,4For patients diagnosed with metastatic breast cancer, five-year survival rates are low.5

About one in five breast cancers overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells, which is associated with aggressive disease.4Several unmet needs remain today in HER2 positive metastatic breast cancer. Many tumors advance to the point where no currently approved HER2 targeting treatment continues to control the disease, and there is no current standard of care for HER2 positive tumors after treatment with trastuzumab, pertuzumab and T-DM1.1,6

About [Fam-] Trastuzumab Deruxtecan

[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia. In addition to DESTINY-Breast03 and DESTINY-Breast02 phase 3 trials, [fam-] trastuzumab deruxtecan is in pivotal phase 2 clinical development for HER2 positive metastatic breast cancer resistant or refractory to ado-trastuzumab emtansine (DESTINY-Breast01); pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01); phase 2 development for HER2 expressing advanced colorectal cancer; phase 2 development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC; and, phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancer.

[Fam-] trastuzumab deruxtecan has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). [Fam-] trastuzumab deruxtecan has received SAKIGAKE Designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On September 25, 2018 Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported updated interim clinical data for LOXO-292 from the global Phase 1/2 LIBRETTO-001 trial in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who were initially included in the LOXO-292 presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Loxo Oncology, SEP 25, 2018, View Source [SID1234529597]). In these 38 patients, approximately 3.5 months of additional patient follow-up were available, as were first follow-up scans for the eight patients most recently enrolled. Twenty-five of 26 (96%) responding patients remained on therapy, with median follow-up of 9.5 months. Inclusion of new restaging data for the most recently enrolled patients resulted in a 68% confirmed overall response rate in the presented subset. These data are being presented today at the 2018 IASLC 19th World Conference on Lung Cancer in Toronto (abstract 13922).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am pleased that the attendees of World Lung were able to see the activity of LOXO-292 in RET fusion-positive lung cancer," said Geoffrey R. Oxnard, M.D., associate professor of medicine at Harvard Medical School and thoracic oncologist at Dana-Farber Cancer Institute. "It has been just a few months since ASCO (Free ASCO Whitepaper), but the additional follow-up afforded by today’s data provide encouraging evidence that LOXO-292 can deliver durable responses in heavily pre-treated patients. It was additionally reassuring to see that that LOXO-292 appears to be well tolerated at the Phase 2 dose of 160 mg BID. With Breakthrough Therapy Designation in hand, LOXO-292 is moving rapidly through clinical development, so it is important for investigators and patients to pay attention to this emerging target and class of medicines."

Trial Background

LIBRETTO-001 is a Phase 1/2 trial of LOXO-292 in advanced cancer patients who primarily have activating RET alterations. LIBRETTO-001 contains a Phase 1 dose escalation phase and a Phase 2 dose expansion phase. The primary endpoint of the Phase 1 is the determination of the maximum tolerated dose (MTD) or recommended dose for further study. Secondary endpoints include safety, overall response rate (by RECIST 1.1) and duration of response. Initial clinical data were first reported at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Key Data Presented

The data presented today were based on a July 19, 2018 data cut-off date and included the 38 patients with RET fusion-positive NSCLC who were initially included in the LOXO-292 presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.

Patients were heavily pretreated, having received a median of three prior systemic treatment regimens. Thirty-nine percent had received both prior platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy.

With 3.5 months of additional follow-up since the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting presentation, LOXO-292 demonstrated encouraging, early evidence of durable activity, with 25 of 26 (96%) responding RET fusion-positive NSCLC patients remaining on therapy and 24 of 26 (92%) remaining in response (median follow-up of 8.5 months for all 38 patients; median follow-up of 9.5 months for responding patients). The longest responding patient on therapy was the first RET fusion-positive NSCLC patient enrolled, who had been on therapy for more than 14 months as of the data cut-off date.

The new data cutoff date allowed for the inclusion of first follow-up scans for eight patients who had not had any post-baseline response assessment as of the ASCO (Free ASCO Whitepaper) presentation. Of 38 patients with RET fusion-positive NSCLC, 26 demonstrated an objective response by RECIST 1.1 (all partial responses, including one patient with an unconfirmed partial response awaiting a confirmatory response assessment) and six additional patients demonstrated evidence of tumor regression (-3% to -29%). The overall response rate was 68% (26/38) (95% CI: 51%-83%) and the confirmed overall response rate was 68% (25/37) (95% CI: 50%-82%). Response assessments were performed by the local clinical trial sites.

Anti-tumor activity was observed regardless of RET fusion partner (including KIF5B) and prior treatment, including chemotherapy, immunotherapy and multikinase inhibitors. Four patients had RECIST target lesions in the central nervous system (CNS) and all four exhibited confirmed intracranial responses by RECIST 1.1 (one complete response, three partial responses).

Of the 82 patients in the safety analysis, most treatment-emergent adverse events were Grade 1 in severity and judged by the investigator as not related to LOXO-292. The treatment-emergent adverse events observed in ≥10% of patients, regardless of relationship to LOXO-292, were diarrhea (15% Grade 1, 7% Grade 2, 1% Grade 3), fatigue (9% Grade 1, 13% Grade 2, 0% ≥Grade 3), dry mouth (21% Grade 1, 0% ≥Grade 2), constipation (17% Grade 1, 2% Grade 2, 0% ≥Grade 3), hypomagnesemia (12% Grade 1, 1% Grade 2, 0% ≥Grade 3), cough (11% Grade 1, 1% Grade 2, 0% ≥Grade 3), headache (10% Grade 1, 1% Grade 2, 1% Grade 3) and nausea (9% Grade 1, 4% Grade 2, 0% ≥Grade 3). Four patients experienced adverse events ≥Grade 3 that were attributed to LOXO-292 (all Grade 3): tumor lysis syndrome, increased ALT/AST, diarrhea, and thrombocytopenia. All resolved with dose interruption. 160mg BID has been advanced as the Phase 2 dose, with dose exploration at 200mg BID ongoing to further characterize LOXO-292 safety and efficacy.

The presentation will be available online at View Source

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

On September 25, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported the European Commission (EC) has granted marketing authorization to UDENYCA (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar (Press release, Coherus Biosciences, SEP 25, 2018, View Source [SID1234531697]). UDENYCA is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Today’s EC approval decision is the first marketing authorization for Coherus, an important step forward in realizing our mission of increasing access to biologic treatments to patients globally," said Denny Lanfear, President and CEO of Coherus BioSciences. "This decision is the result of a concerted effort across analytical, process, manufacturing and clinical/regulatory, as well as intellectual property, the pillars of our product platform. I would like to congratulate my team and our partners for their dedication and extraordinary efforts in achieving this significant milestone."

"We look forward to the anticipated US approval later this year and to executing on a vigorous launch, supported by our strategic manufacturing partners in the United States, meeting the highest product quality and production reliability standards," said Vince Anicetti, Chief Operating Officer of Coherus BioSciences.

UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date of November 3, 2018.

About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a growth-colony-stimulating-factor designed to decrease the chance of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

UDENYCA is not yet available for commercial sale.

For more information about UDENYCA contact Coherus BioSciences Medical Information at (800) 4-UDENYCA (1-800-483-3692)

Neulasta is a registered trademark of Amgen Inc.

On September 25, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, will present a corporate overview at the Cantor Fitzgerald Global Healthcare Conference on Monday, October 1, 2018 at 9:30 a.m. Eastern time (Press release, Advaxis, SEP 25, 2018, View Source [SID1234529565]). The conference will be held October 1-3, 2018 at the InterContinental New York Barclay Hotel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mr. Berlin’s presentation will be webcast live and available for replay in the Investors section of the Company’s website at www.ir.advaxis.com.