On January 2, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that in December 2017 the first patient was dosed in a global Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, in patients with previously untreated advanced hepatocellular carcinoma (HCC or liver cancer) (Press release, BeiGene, JAN 2, 2018, View Source;p=RssLanding&cat=news&id=2324332 [SID1234522801]). Along with two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer, and a global Phase 3 trial in patients with non-small cell lung cancer, tislelizumab is now being evaluated in pivotal trials in four distinct indications.

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"We are pleased to announce the initiation of this global Phase 3 trial of tislelizumab as part of our collaboration with our partner Celgene. We look forward to continuing to leverage our strong presence in Asia and global clinical development organization to broadly develop tislelizumab," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Advanced liver cancer is a serious and prevalent disease, with few treatment options. We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab in a head-to-head comparison to sorafenib, the current global standard of care for advanced liver cancer," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

The Phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab versus sorafenib as a potential first-line treatment in patients with unresectable HCC. Approximately 640 patients will be enrolled at approximately 110 cancer centers in China, the United States, Japan, the United Kingdom, Germany, Spain, Czech Republic, France, and Italy. Patients will be randomized to receive either tislelizumab at 200 mg every three weeks or sorafenib at 400 mg twice daily.

The trial’s primary endpoint is overall survival, and secondary endpoints include overall response rate, progression free survival, duration of response, time to progression, health-related quality of life, disease control rate, clinical benefit rate, and safety profile.

"The expected median survival in patients with advanced liver cancer is typically less than one year, and patients can face difficulties tolerating sorafenib," said Qin Shukui, M.D., Hospital Deputy Director and Director of the Cancer Center at the People’s Liberation Army 81 Hospital, Nanjing, China, and co-lead investigator of the trial. "I look forward to testing tislelizumab in the hopes that we can further advance treatment options for patients with advanced liver cancer."

"I am excited for the opportunity to evaluate the safety and efficacy of tislelizumab, which has been dosed in more than 850 patients in either monotherapy or combination clinical trials. Based on preliminary data from a dose expansion cohort of HCC patients in a Phase 1 trial, we are hopeful that tislelizumab will be well-tolerated and exhibit meaningful anti-tumor activity in this Phase 3 trial," said Andrew Zhu, M.D., Ph.D., Director of Liver Cancer Research at Massachusetts General Hospital, Professor of Medicine at Harvard Medical School and co-lead investigator of the trial.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Hepatocellular Carcinoma

HCC is a major global health problem, accounting for 85-90 percent of all reported cases of liver cancer.i Liver cancer is the sixth most common type of cancer, with an estimated 782,000 new cases per year worldwide; it was also the second most common cause of cancer-related mortality, responsible for an estimated 746,000 deaths.ii China accounts for approximately 50 percent of both new HCC cases and HCC-related deaths worldwide.ii

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 2, 2018 Rubius Therapeutics, a biotechnology company pioneering the creation of a new class of extraordinarily active, ready-to-use and life-changing cellular therapies, reported that David Epstein, executive chairman of Rubius, will provide a corporate presentation at the 36th Annual J.P. Morgan Healthcare Conference (Press release, Rubius Therapeutics, JAN 2, 2018, View Source [SID1234522866]).

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The presentation will take place at 7:30 a.m. PST (10:30 a.m. EST) on Monday, January 8, 2018 at the Westin St. Francis Hotel in San Francisco.

On January 2, 2018 Aptose Biosciences Inc. (Nasdaq:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the upcoming Biotech ShowcaseTM 2018 Conference on Monday, January 8th, 2018 at 11:00 a.m. PST in San Francisco, CA (Press release, Aptose Biosciences, JAN 2, 2018, View Source [SID1234522795]).

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Conference Presentation Details:

Date: Monday, January 8, 2018
Time: 11:00 a.m. PST
Location: Track Yosemite – C (Ballroom Level)
Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102
Webcast: View Source;tp_key=e58ab4bdea

The audio webcast will be archived shortly after the live event and will be available through the Aptose website at www.aptose.com.

The Company will also be hosting institutional investor and partnering meetings at the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018.

To schedule a meeting with Aptose, investors can register on the online system managed by the Company’s US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at [email protected].

On January 2, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Jazz Pharmaceuticals, JAN 2, 2018, View Source;p=RssLanding&cat=news&id=2324485 [SID1234522819]).

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Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update at the conference on Monday, January 8, 2018 at 9:30 a.m. PST / 5:30 p.m. GMT.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On January 2, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma (Press release, Seattle Genetics, JAN 2, 2018, View Source;p=RssLanding&cat=news&id=2324372 [SID1234522805]). The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018. The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called ECHELON-1 that was designed to determine if ADCETRIS in combination with chemotherapy could extend modified progression-free survival (modified PFS) in previously untreated advanced classical Hodgkin lymphoma patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

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"The FDA’s filing of our supplemental BLA with Priority Review represents a significant milestone in our goal to redefine the frontline treatment of advanced Hodgkin lymphoma," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We recently reported the primary data from the phase 3 ECHELON-1 clinical trial in the Plenary Scientific Session of the 2017 ASH (Free ASH Whitepaper) Annual Meeting with simultaneous publication in the New England Journal of Medicine. The data demonstrated superior activity of the ADCETRIS-containing regimen over standard of care, and we are working with the FDA to make this bleomycin-free regimen available to newly diagnosed advanced Hodgkin lymphoma patients as soon as possible."

In October 2017, the FDA granted ADCETRIS Breakthrough Therapy Designation based on the ECHELON-1 study results. The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies in one or more clinically significant endpoints.

The ECHELON-1 study evaluated a combination of ADCETRIS plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen, ABVD (which includes bleomycin), in frontline advanced classical Hodgkin lymphoma. The positive results from the phase 3 ECHELON-1 trial were featured in the Plenary Scientific Session of the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting with simultaneous publication in the New England Journal of Medicine in December 2017. Results from the ECHELON-1 trial in 1,334 Hodgkin lymphoma patients included:

The trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (p-value=0.035). This corresponds to a 23 percent reduction in the risk of progression, death or need for additional anticancer therapy. Per IRF assessment, the two-year modified PFS rate for patients in the ADCETRIS plus AVD arm was 82.1 percent compared to 77.2 percent in the control arm.
The investigator assessment of modified PFS also demonstrated a statistically significant advantage for ADCETRIS plus AVD versus the control arm of ABVD (p-value <0.01).
All secondary endpoints, including interim analysis of overall survival, trended in favor of the ADCETRIS plus AVD arm.
The safety profile of ADCETRIS plus AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.
ECHELON-1 Phase 3 Clinical Trial Design
The randomized, open-label, phase 3 trial is investigating ADCETRIS plus AVD versus ABVD as frontline therapy in patients with advanced classical Hodgkin lymphoma. The primary endpoint is modified PFS per Independent Review Facility assessment using the Revised Response Criteria for Malignant Lymphoma. Modified PFS is defined as the time to progression, death or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy per Independent Review Facility. Secondary endpoints include overall survival, complete remission and safety. The multi-center trial was conducted in North America, Europe, South America, Australia, Asia and Africa. The study enrolled 1,334 patients who had a histologically-confirmed diagnosis of Stage III or IV classical Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy. The ECHELON-1 trial was conducted under a Special Protocol Assessment (SPA) agreement from the FDA and the trial also received EMA scientific advice.

Please see Important Safety Information at the end of this press release.

About Classical Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30. Although the currently used standard of care frontline combination chemotherapy can result in durable responses, up to 30 percent of patients with advanced Hodgkin lymphoma relapse or are refractory to frontline treatment.

According to the American Cancer Society, approximately 8,260 cases of Hodgkin lymphoma will be diagnosed in the United States during 2017 and more than 1,000 will die from the disease. According to the Lymphoma Coalition, over 62,000 people (including early and advanced stage) worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS
ADCETRIS is being evaluated broadly in more than 70 clinical trials, including three phase 3 studies: the completed ECHELON-1 trial in frontline classical Hodgkin lymphoma that supported the recent FDA Breakthrough Therapy Designation and submission of the supplemental Biologics License Application (BLA) for use in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for four indications: (1) regular approval for adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, (2) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (4) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.