Luminex Corporation To Release Fourth Quarter and Full-Year 2019 Results After Market Close On February 10, 2020

On January 23, 2020 Luminex Corporation (NASDAQ: LMNX) reported that it plans to report results for the fourth quarter and full-year ended December 31, 2019 on Monday, February 10, 2020 after the market close (Press release, Luminex, JAN 23, 2020, View Source [SID1234553476]).

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!

The company will host a conference call that day at 5:00 p.m. Eastern Time to discuss operating highlights and financial results.

The conference call will be webcast live and may be accessed at Luminex’s Investor Relations website at investor.luminexcorp.com. The presentation slides will be posted to our Investor Relations website after the market close on February 10, 2020. Analysts may participate on the conference call by dialing (877) 930-7053 (U.S.) or (253) 336-7290 (outside the U.S.). The access code is 1593082. The webcast will be archived for six months on our website using the ‘replay’ link.

CStone successfully hosted the first U.S. R&D Day in New York

On January 23, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that it successfully hosted its 2020 U.S. R&D Day in New York on January 21 (Press release, CStone Pharmaceauticals, JAN 23, 2020, View Source [SID1234553474]). CStone’s management team highlighted major milestones the Company had achieved in research, clinical development, business development and commercialization strategies since its establishment. The management team also provided updates on the progress of the Company’s pipeline. Leading academics and key opinion leaders from China and the United States provided insights on the latest trends in the transformation of cancer treatments in China.

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!

Targeting five indications, CStone plans to submit five NDAs in 2020 for CS1001, an anti-PD-L1 monoclonal antibody; pralsetinib, a RET inhibitor; and AYVAKITTM (avapritinib), a KIT and PDGFRA inhibitor, in Mainland China and Taiwan. The Company plans to release the top-line data from seven ongoing clinical trials of these three drug candidates. CStone will focus on developing and commercializing innovative immuno-oncology therapies and precision medicines to address the unmet needs in cancer treatment in China and globally, and drive its Pipeline 2.0 strategy to accelerate its transition toward a commercial-stage biopharmaceutical company with a unique and efficient R&D platform. Moreover, the Company plans to submit NDAs for around 10 indications for four products in the next two to three years.

"China’s biopharmaceutical industry is undergoing significant transformation, and CStone is at the forefront of this paradigm shift. With a strategy focused on large cancer indications in China, unmet patient needs, and combination therapies, we are currently conducting over 30 clinical trials, including 13 registrational studies, and 14 combination trials," said Dr. Frank Jiang, Chairman and CEO of CStone. "We are very pleased that Shirley Zhao has joined us as General Manager for Greater China and Head of Commercial Operations, at this inflection point in CStone’s transition from clinical-stage to commercial-stage. In the next two to three years, Shirley will lead the establishment of CStone’s commercialization capabilities and the launch of multiple innovative products in the Greater China region. Leveraging our unique and highly efficient early-stage clinical development platform, we will continue to strengthen our pipeline and drive biopharmaceutical innovations in China."

Event highlights:

CStone’s achievements

CStone has established a clinical development-driven business model and built a world-class clinical team with significant experience in translational medicine and clinical development. In addition, the Scientific Advisory Board comprised of four internationally renowned immuno-oncologists has substantially strengthened the Company’s R&D capabilities in immunotherapies and precision medicines, further enhancing and optimizing CStone’s R&D strategies and product pipeline.
CStone has built a risk-balanced and highly competitive immunotherapy-focused pipeline. Among the Company’s 15 cancer drug candidates, five are in pivotal late-stage clinical development. AYVAKITTM (avapritinib), developed by Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals have received NDA approvals from the U.S. FDA.
Among these trials, the clinical studies of CS1001, an anti-PD-L1 monoclonal antibody, have achieved promising clinical results with patients treated with CS1001 exceeding one thousand. In 2019, CStone released encouraging data from the trials of CS1001 in esophageal carcinoma and a number of other large cancer indications in China at major medical conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Chinese Society of Clinical Oncology (CSCO), and the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings.
The two in-licensed products of CStone’s pipeline candidates that have received NDA approvals from the U.S. FDA are AYVAKITTM (avapritinib), developed by the partner company, Blueprint Medicines, and TIBSOVO (ivosidenib), developed by Agios Pharmaceuticals. Moreover, Blueprint Medicine has initiated a rolling NDA submission to the U.S. FDA for pralsetinib. All three candidate drugs are being investigated in multiple registrational trials in China.
In December, 2019, the global Phase III VOYAGER trial of avapritinib in third-line gastrointestinal stromal tumors (GIST), and the global Phase I/II ARROW study of pralsetinib in second- and later-line non-small cell lung cancer (NSCLC) have both completed their targeted enrollments of Chinese patients ahead of schedule.
CStone developed comprehensive early-stage programs and is scaling up its combination therapy-focused pipeline. The Company has made significant progress with two of its backbone immunotherapy assets, CS1002, an anti-CTLA-4 monoclonal antibody; and CS1003, an anti-PD-1 monoclonal antibody. Both assets generated promising results as monotherapies in Phase I studies, and CS1003 has already entered a global Phase III registrational trial. In the development of combination therapies, CStone recently initiated multiple combination trials and will continue to advance these combination studies in 2020.
Leveraging a unique and highly efficient R&D platform and an innovation ecosystem, CStone has further strengthened its Pipeline 2.0. The Company will continue to develop first-in-class and best-in-class drugs and therapies to maintain its lead in innovations.
In 2019, CStone advanced two drug candidates in its pipeline into clinical development, and commenced a dozen preclinical research initiatives.
Major milestones expected in 2020 include:

One New Drug Application approval
TIBSOVO, for the treatment of R/R AML, is expected to receive an NDA approval in Taiwan and become CStone’s first commercialized product in the Greater China region.
5 NDA submissions
CStone plans to submit five new drug applications in Mainland China and Taiwan, for CS1001, pralsetinib, and avapritinib.
Seven clinical trial data releases
CStone plans to release top-line data from seven clinical trials of CS1001 (an anti-PD-L1 monoclonal antibody), pralsetinib, and avapritinib, and six of these trials are registrational studies.
Development strategies for 2020

To consolidate resources to focus on the delivery of the 13 milestones.
CStone will build a commercial organization for Greater China equipped with core commercialization capabilities to enable the Company’s successful transition to the commercial-stage.
CStone will continue to seek strategic collaborations with key players, to drive the future growth of the company.
Leveraging its internal R&D, CStone will transition into its Pipeline 2.0 and drive the sustained growth of the Company. In the next three to five years, CStone will add first-in-class and best-in-class multi-specific monoclonal antibodies and molecular backbone assets to its pipeline. The Company plans to further explore tumor microenvironment modulators, cancer vaccines, new pathway inhibitors, and innovative combination approaches that could potentially bolster the effect of anti-PD-(L)1 antibodies.
New product launches

In the next two to three years, CStone plans to launch four of its drug candidates, including avapritinib, pralsetinib, ivosidenib and the anti-PD-L1 monoclonal antibody CS1001, in the Greater China region, targeting a total of 10 cancer indications.
Key messages from KOL speakers

Dr. Paul Bunn, MD, former President of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Distinguished Professor at University of Colorado Cancer Center, commented that latest clinical data of the RET inhibitor pralsetinib were very encouraging. The trial has already completed the patient target enrollment, which included naïve patients and patients who have received platinum-based chemotherapy. He expects this precision medicine will benefit cancer patients in the future.
Dr. Eytan Stein, MD, Professor at the Memorial Sloan Kettering Cancer Center, commented that compared to current standard chemotherapies, ivosidenib could bring significant clinical benefits to AML patients and its high-selectivity could broaden clinical benefits to cancer patients with an IDH1-mutation.
Dr. Yilong Wu, MD, President of the Chinese Thoracic Oncology Group (C-TONG), past president of Chinese Society of Clinical Oncology (CSCO), tenured professor of Guangdong Provincial People’s Hospital and Guangdong Lung Cancer Research Institute, emphasized that CStone has initiated three registrational lung cancer trials and the Company will play an important role in the lung cancer field in China.
– CS1001 is currently being investigated in the Phase III GEMSTONE-301 study in patients with locally advanced or unresectable NSCLC, and it could potentially benefit a wide range of patients. Considering the clinical practices in China, the trial also included patients who had received either concomitant or sequential radiochemotherapy. In addition, CS1001 is also being investigated in a Phase III trial in first-line Stage IV NSCLC.
– The study of pralsetinib in RET-fusion NSCLC has demonstrated promising clinical utility. Due to the persistent high incident rate of lung cancers and the lack of any effective treatment for RET-mutant cancers, pralsetinib has the potential of effectively addressing the current treatment gap in RET-fusion NSCLC in China.
Dr. Jian Li, MD, Professor at Beijing Cancer Hospital and Chairman-elect of the Chinese Society of Clinical Oncology’s (CSCO) Committee on GIST, acknowledged avapritinib’s therapeutic promise in the treatment of GIST in China. Avapritinib is a first-in-class precision medicine approved by the U.S. FDA for the treatment of GIST, and there is currently no effective treatment for PDGFRA D842V mutant GIST in China. Available clinical data of avapritinib in PDGFRA exon 18 mutant GIST (including PDGFRA D842V mutations) have demonstrated compelling antitumor activity and a more tolerable safety profile. The drug could significantly benefit GIST patients who are in need of effective treatment options.
Dr. Weiping Zou, MD, PhD, Professor at University of Michigan, Director of the Center of Excellence for Cancer Immunology and Immunotherapy, and Chair of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) Cancer Immunology Working Group (CIMM), commented that CStone has made significant progress in the past three years, and he will likely to further collaborate with the Company in selecting Class I drug targets for future development and he looks forward to facilitating CStone’s transition to Pipeline 2.0.

eHealth, Inc. Announces Preliminary Results for the Fourth Quarter and Fiscal Year 2019

On January 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange in the United States, reported preliminary, unaudited financial results and select operating metrics for the fourth quarter and fiscal year ended December 31, 2019 (Press release, eHealthInsurance, JAN 23, 2020, View Source [SID1234553473]).

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 proud of our achievements in 2019. After raising our guidance twice in the past year, we significantly exceeded our financial and operating targets driven by consistently strong execution throughout the year. 2019 culminated with an exceptional performance by our team during the fourth quarter Medicare annual enrollment period. Our marketing and business development organizations drove record consumer demand to the eHealth platform allowing us to grow fourth quarter approved Medicare members in excess of 85%," commented Scott Flanders, chief executive officer of eHealth. "We remain excited about the Medicare market opportunity and significant growth potential ahead of us and are looking forward to sharing our outlook for 2020 as part of our fourth quarter earnings release next month."

The preliminary, unaudited financial results and selected operating metrics included in this press release are based on information available as of January 23, 2020 and management’s initial review of operations for the fourth quarter and year ended December 31, 2019. They remain subject to change based on management’s ongoing review of the company’s fourth-quarter and full year results and are forward-looking statements. eHealth assumes no obligation to update these statements. The actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

As part of the year-end closing process, the company is enhancing the manner in which it estimates residual or "tail" revenue from the company’s Medicare Advantage members approved in prior periods. Since the adoption of Accounting Standards Codification (ASC) 606, the company’s cash collections for Medicare Advantage policies have in general exceeded initial lifetime value estimates. This dynamic has contributed in past quarters to the recognition of increasing amounts of residual or "tail" revenue from Medicare members approved in prior periods. Our preliminary results exclude the positive impact of changes in estimates for expected collections for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019. The company plans to include the results of any such changes in estimates as well as full financial and operating results as part of its fourth quarter and full year 2019 earnings release.

Fourth Quarter and Fiscal Year 2019 Preliminary Results

Excluding any positive impact from the changes in estimates to residual revenue for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019, we expect the following fourth quarter and fiscal year 2019 results:

Revenue for the fourth quarter of 2019 is expected to be in the range of $257.5 to $259.5 million with expected fourth quarter revenue from the Medicare segment in the range of $239.0 to $240.5 million.
GAAP net income for the fourth quarter of 2019 is expected to be in the range of $53.0 to $55.0 million. Adjusted EBITDA(a) for the fourth quarter of 2019 is expected to be in the range of $98.5 to $100.5 million.
Revenue for the year ended December 31, 2019 is expected to be in the range of $462.0 to $464.0 million as compared to the company’s guidance of $365.0 to $385.0 million. Revenue from the Medicare segment for the full year 2019 is expected to be in the range of $403.5 to $405.0 million as compared to the company’s guidance of $318.0 to $333.0 million.
GAAP net income for the year ended December 31, 2019 is expected to be in the range of $31.0 to $33.0 million as compared to the company’s guidance of $20.9 to $25.9 million.
Adjusted EBITDA(a) for the year ended December 31, 2019 is expected to be in the range of $89.0 to $91.0 million as compared to the company’s guidance of $65.0 to $70.0 million.

Adjusted EBITDA is calculated by adding stock-based compensation expense, depreciation and amortization expense, change in fair value of earnout liability, amortization of intangible assets, other income, net of expenses and provision for income taxes to GAAP net income. See "Non-GAAP Financial Information Reconciliations."

Approved Members

The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, grew 88% during the fourth quarter of 2019 compared to the fourth quarter of 2018. The number of approved members for Medicare Advantage products grew 100% over the same time period. For the full year 2019, the number of approved members for all Medicare products grew 81% compared to the full year 2018 with approved members for Medicare Advantage products growing 88% over the same time period.

The number of approved members for major medical individual and family plan (IFP) products grew 1% during the fourth quarter of 2019 compared to the fourth quarter a year ago. For the full year 2019, the number of approved members for IFP products declined 25% compared to 2018. The decline in approved IFP members reflects weaker than expected enrollment activity in the overall individual and family health insurance market as well as our continuing emphasis on the Medicare business in allocating our marketing resources.

Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Sixth Consecutive Year

On January 23, 2020 Certara, the global model-informed drug development and decision support leader, reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or consulting services (Press release, Certara, JAN 23, 2020, View Source [SID1234553472]). This result affirms the pharmaceutical industry’s dedication to employing model-informed drug development approaches for informing key clinical testing decisions, resulting in reduced cost and increased speed in bringing new drugs to patients.

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!

"We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA," said Certara’s CEO Dr. William Feehery. "Certara’s Simcyp, Phoenix and Global Submit software platforms have been widely used by both the FDA and the biopharmaceutical industry during the past several years for drug development and regulatory review. In addition to the use of our technology, our expert consulting services teams supported the development of therapies for patients with cancer, central nervous system diseases, infectious diseases, and rare diseases in the class of 2019."

During her speech at the Breakthroughs in Medicine conference in Rancho Palos Verdes, CA last September, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of the Agency’s commitment to innovation in drug development. Certara’s mission is closely aligned with that commitment, which was outlined by the Agency in its Congressional testimony on implementing the 21st Century Cures Act:

"As part of FDA’s broader innovation initiative, we are encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations to allow an evaluation of a product’s safety and effectiveness…CDER and FDA’s Center for Biologics Evaluation and Research (CBER) are currently deploying these tools to help predict clinical outcomes, inform trial design, support evidence of effectiveness, and evaluate potential adverse event mechanisms."

Certara’s innovations have had a profound impact on accelerating and improving the efficiency of drug development. During the past six years, Certara’s technology and/or consulting services have been used to inform and expedite the development of about 250 novel therapies. In 2019 alone, Certara provided technology, consulting and/or regulatory writing and submission support for 11 oncology drugs, 12 drugs for orphan diseases, and 16 drugs that received priority or accelerated review. Certara’s quantitative and integrated approach to drug development has enabled sponsors to reduce the size and duration of clinical trials, develop dosing strategies for special populations, such as pediatrics, evaluate alternative formulations, seek expedited regulatory pathways, and leverage in silico models in lieu of conducting clinical trials.

Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma

On January 23, 2020 Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial (Press release, Epizyme, JAN 23, 2020, View Source [SID1234553470]).

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!

"Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies," said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial. "The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES."

"Today’s accelerated approval of TAZVERIK is a landmark event for people with ES and represents our dedication to our mission of rewriting treatment for people with cancer and other serious diseases," said Robert Bazemore, president and chief executive officer of Epizyme. "TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days."

"For people with epithelioid sarcoma, an aggressive life threatening cancer that affects young adults, having new treatment options can offer much needed hope," added Denise Reinke, MS, NP, MBA, president and chief executive officer of the Sarcoma Alliance for Research through Collaboration (SARC) and co-founder of the Sarcoma Coalition.

Dr. Shefali Agarwal, chief medical officer, commented, "Discovering, developing and obtaining FDA approval for TAZVERIK, with its novel mechanism of action, is the result of years of work and commitment by many people, including the patients, caregivers and physicians who have participated in our clinical trials, along with the talented team at Epizyme. We are tremendously proud of this important milestone and look forward to further advancing clinical development of tazemetostat for multiple types of cancers."

Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The company’s ongoing, global, randomized, controlled confirmatory trial assessing the combination of TAZVERIK plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES is underway.

In addition, Epizyme will conduct certain post-marketing activities, including clinical pharmacology evaluations to assess the effect of TAZVERIK on liver function and the effect of CYP3A inhibitors and inducers on TAZVERIK to inform aspects of the prescribing information. The company will also expand enrollment in Cohort 6 of its Phase 2 study, which has enrolled 44 patients to date, for a total of at least 60 epithelioid sarcoma patients. This expansion is intended to provide more patient experience for potential future inclusion in the label.

Phase 2 Epithelioid Sarcoma Cohort Efficacy Data
The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort (Cohort 5) of a multi-center study (Study EZH-202, NCT02601950) in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients were required to have INI1 loss, detected using local tests, and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Patients received TAZVERIK 800 mg orally twice daily until disease progression or unacceptable toxicity. Tumor response assessments were performed every 8 weeks. The major efficacy outcome measures were confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR) and duration of response (DOR). Median duration of follow-up was 14 months (range 0.4 to 31).

Among the 62 patients who received TAZVERIK, median age was 34 years (range 16 to 79); 63% were male, 76% were White, 11% were Asian, 44% had proximal disease, 92% had an ECOG PS of 0 or 1, and 8% had an ECOG PS of 2. Prior surgery occurred in 77% of patients; 61% received prior systemic chemotherapy.

In the total 62 patients treated, the ORR (95% confidence interval) was 15% (7%, 26%), with 1.6% of patients achieving a complete response and 13% achieving a partial response. Among responders in the trial, 67% had a duration of response of six months or longer.

Serious adverse reactions occurred in 37% of patients receiving TAZVERIK. Serious adverse reactions in ≥3% of patients who received TAZVERIK were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress.

One patient (2%) permanently discontinued TAZVERIK due to an adverse reaction of altered mood.

Dosage interruptions due to an adverse reaction occurred in 34% of patients who received TAZVERIK. The most frequent adverse reactions requiring dosage interruptions in ≥3% were hemorrhage, increased alanine aminotransferase (ALT), and increased aspartate aminotransferase (AST).

Dose reduction due to an adverse reaction occurred in one (2%) patient who received TAZVERIK; the dose was reduced in this patient for decreased appetite.

The most common adverse reactions (≥20%) were pain, fatigue, nausea, decreased appetite, vomiting and constipation.

View the U.S. Full Prescribing Information here: Epizyme.com

About TAZVERIK
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Dosage and Administration
The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 668 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.6% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL).
Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.
Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurring in >3% were hemorrhage, pleural effusion, skin infection, dyspnea and pain. The most common (≥20%) adverse events were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%) and constipation (21%).
Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
Avoid coadministration of strong or moderate CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.
Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.
Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.
Investor Conference Call
Epizyme will host an investor conference call and webcast tonight at 5:30 p.m. ET. To participate in the call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 2339029. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived on the website for 60 days.