On August 9, 2021 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported that Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1) (Press release, AstraZeneca, AUG 9, 2021, View Source [SID1234586068]).

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At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival (PFS) showing a highly statistically significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

In DESTINY-Breast03, Enhertu also showed a strong trend toward improved overall survival (OS) compared to T-DM1 in a key secondary endpoint, although the OS data are still immature. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events.

Susan Galbraith, Executive Vice President, Oncology R&D, said: "There is a continued need for new options and better outcomes for patients with HER2-positive metastatic breast cancer who often experience disease progression after initial treatment with available standards of care. These transformative progression-free survival results demonstrate the superiority of Enhertu compared to T-DM1, and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings."

Ken Takeshita, Global Head, Research and Development, Daiichi Sankyo, said: "DESTINY-Breast03 is the first global Phase III head-to-head trial of Enhertu against an active control and supports the potential of this medicine to become the new standard of care for patients with HER2-positive metastatic breast cancer following initial treatment with trastuzumab and a taxane. We believe this highly sophisticated and specifically engineered ADC is fulfilling its promise to reshape the treatment of HER2-positive metastatic breast cancer, with the goal to move into earlier lines of treatment for HER2-positive breast cancer and many other HER2-expressing tumour types across our broad clinical trial programme."

The data will be presented at an upcoming medical meeting and shared with health authorities.

Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting in the US, Japan, the EU and several other countries based on the results from the DESTINY-Breast01 trial.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

HER2-positive breast cancer
Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide.1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five patients with breast cancer are considered HER2-positive.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast, gastric, lung and colorectal cancers.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and a poor prognosis in breast cancer.4

Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.5 More effective options are needed to further delay progression and extend survival.5-7

DESTINY-Breast03
DESTINY-Breast03 is a global head-to-head, randomised, open-label, registrational Phase III trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) 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 PFS based on blinded independent central review. Secondary efficacy endpoints include OS, objective response rate, duration of response, clinical benefit rate, PFS based on investigator assessment and safety.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in Canada, the EU, Israel, Japan, the UK and the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is also approved in Israel, Japan and the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Enhertu was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the "ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers," based on data from both the DESTINY-CRC01 and DESTINY-Gastric01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC), based on the interim results of the HER2-mutated cohort of the DESTINY-Lung01 trial.

In May 2020, Enhertu also received Breakthrough Therapy Designation for the treatment of patients with metastatic NSCLC whose tumours have a HER2-mutation and with disease progression on or after platinum-based therapy.

Daiichi Sankyo collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral SERD and potential new medicine AZD9833.

PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 9, 2021 Targovax ASA (OSE: TRVX) reported that it will announce its second quarter and first half 2021 results on Wednesday 18 August 2021 (Press release, Targovax, AUG 9, 2021, View Source [SID1234586067]). An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 am CET.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET.

Presentation

As a consequence of the Corona situation, there will only be a virtual presentation of the results with a live webcast 18 August at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On August 8, 2021 ImmVira reported that MVR-C5252 targeting Glioblastoma has received the U.S. FDA clearance to proceed with clinical trial on August 6, 2021 (Press release, Immvira, AUG 8, 2021, View Source [SID1234586063]).

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Glioma is the most common type of CNS tumors. Glioblastoma ("GBM"), as the most aggressive type of Gliomas, displays the highest grade of malignancy and can occur in the brain or spinal cord with median survival of less than two years. The lack of availability in treatment therapies except surgery and radiation, especially the limited options of drugs, indicate an urgent need for development of a novel therapeutic strategy, particularly for recurrent GBM.

On June 11, 2021, Daiichi Sankyo Company, Limited announced that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for DELYTACT (teserpaturev/G47∆), an oncolytic virus("OV"), for the treatment of patients with GBM, becoming the world’s first OV therapy approved for brain tumors. The approval of DELYTACT in Japan is a validation of oHSV-1 modality. Moreover, FDA’s approval on Breakthrough Therapy Status of two OV products targeting GBM in recent years symbolizes the favorable forward-looking for OV modalities over the same indication.

Leveraging ImmVira’s OvPENS development platform, MVR-C5252 is designed specifically for the treatment of malignant glioma. This product has been further genetically engineered on the basis of MVR-T3011 (also known as T3011) by specific attenuation to achieve on-target malignant gliocyte killing while maintaining safety profile. MVR-C5252 also carries exogenous genes that express IL-12 and PD-1 mAb to promote the immune response of tumor microenvironment for further anti-tumor activity.

The IND clearance of MVR-C5252 in the United States highlights ImmVira’s strong and sustainable research and development capability in designing and synthesizing viral vector with functional specificity, and marks another important step for ImmVira’s pipeline expansion. ImmVira’s OvPENS, the systematic next-generation cancer therapy development platform, is expected to drive more pipelines into clinical stage, expand pipelines to cover broader indications, and capture the large and evolving market of oncolytic virotherapy.

On August 8, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology; and MindRank AI, an innovative AI drug discovery company, reported a long-term strategic partnership on the joint development of first-in-class small-molecule oncology drugs (Press release, Antengene, AUG 8, 2021, View Source [SID1234586062]). To date, MindRank AI has already made contributions to the development of one of Antengene’s pre-clinical stage drug candidates.

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This collaboration marks the establishment of a synergistic alliance between a leading research-driven biopharmaceutical company and an innovative AI-powered drug discovery company to transform drug discovery and development. Antengene has a strong R&D team with global experience in the discovery and development of innovative drugs and proven capability in developing compounds for difficult-to-drug targets. To date, Antengene has built a broad and expanding pipeline of 13 clinical and pre-clinical assets, comprising 8 global rights assets and 5 assets with rights for Asia Pacific markets including the Greater China region. Meanwhile, MindRank AI will deploy its proprietary one-stop AI-driven drug discovery platform, Molecule Pro, and its molecular dynamics platform, Molecule Dance, to support Antengene’s efforts in discovering and developing more first-in-class and best-in-class drug candidates.

Through this collaboration to advance the development of difficult-to-drug targets, Antengene and MindRank AI aim to improve the efficiency and success rate of the current drug discovery process. Both parties hope to address more unmet medical needs by delivering practice-changing therapeutics for patients.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "We are excited about this ground-breaking partnership with MindRank AI, established to accelerate our development of new therapies for difficult-to-drug targets. Antengene has built a pipeline of 13 assets over the past 4 years through both partnerships and in-house discovery. In 2021, we have seen our first in-house developed asset enter into clinical stage. We are confident that this collaboration between two industry leaders will further enhance our in-house discovery capabilities and bring more novel, broader and effective therapeutics to patients around the world."

Mr. Zhangming Niu, Founder and CEO of MindRank AI, noted: "We are very honored to be a strategic partner of Antengene, an industry-leader with robust R&D capabilities and a management team possessing experience in developing and commercializing some of the world’s bestselling oncology drugs. We hope this synergistic collaboration of Antengene’s deep expertise and MindRank’s proprietary AI-powered drug discovery platform will result in more first-in-class oncology drugs for patients globally. Together, we will strive to close more treatment gaps and bring renewed hope to more patients."

On August 8, 2021 Epizyme, Inc. ("Epizyme") (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13),reported a collaboration to research, develop, manufacture and commercialize TAZVERIK in Greater China, including mainland China, Hong Kong, Macau and Taiwan (the "Territory") (Press release, Epizyme, AUG 8, 2021, View Source [SID1234586061]).

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TAZVERIK is a methyltransferase inhibitor of EZH2 developed by Epizyme that is approved by the U.S. Food and Drug Administration ("FDA") for the treatment of certain patients with epithelioid sarcoma ("ES") and certain patients with follicular lymphoma ("FL"). It was approved under FDA accelerated approval based on overall response rate ("ORR") and duration of response ("DOR") in January and June 2020 for ES and FL, respectively.

"We are thrilled to be able to launch this collaboration designed to bring TAZVERIK to patients in Greater China and to have HUTCHMED participate in the global development of TAZVERIK," commented Mr. Robert Bazemore, Epizyme President and CEO. "HUTCHMED is an ideal partner for us in Greater China, given their development and commercial expertise and shared commitment to expanding the value of TAZVERIK through new clinical trials that complement Epizyme’s development plans." Mr. Bazemore continued, "Through this collaboration we anticipate TAZVERIK to become the first EZH2 inhibitor brought to market in Greater China, and we believe the involvement of HUTCHMED in the global development of TAZVERIK can allow for a more rapid, resource-efficient, and geographically inclusive development plan for the U.S. confirmatory EZH-302 trial of TAZVERIK in second line follicular lymphoma (2L FL) in combination with Revlimid plus rituximab (‘R²’)."

"We view the activity of TAZVERIK and its epigenetic mechanism in controlling the expression of certain genes as highly complementary and potentially synergistic with our broad portfolio of novel oncology assets," said Mr. Christian Hogg, CEO of HUTCHMED. "TAZVERIK’s potential for broad applicability and favorable safety profile may provide further inhibition of tumor growth and metastasis when used in combination therapy. This collaboration will accelerate the exploration of the clinical potential of EZH2 inhibition in multiple tumor types, including both hematological malignancies and solid tumors. We believe that Epizyme and HUTCHMED are uniquely positioned to realize these opportunities and thereby rapidly benefit as many patients, both inside and outside China, as possible."

Under the terms of the agreement, HUTCHMED will be responsible for the development and commercialization of TAZVERIK in greater China. Epizyme will receive a US$25 million upfront payment and is eligible to receive up to an additional US$110 million in development and regulatory milestone payments, across up to eight potential indications, and up to an additional US$175 million in sales milestone payments. Epizyme is also eligible to receive tiered royalties of mid -teen to low-twenties-percent based on annual net sales of TAZVERIK in Greater China. In addition, HUTCHMED receives a four-year warrant to acquire up to US$65 million of Epizyme shares at US$11.50 per share. The upfront payment will be funded by HUTCHMED from existing cash resources, and potential milestone payments and royalties are expected to be funded from future cash resources including cash from the sales of TAZVERIK.

HUTCHMED plans to develop and seek approval for TAZVERIK in various hematological and solid tumors, including ES, FL and diffuse large b-cell lymphoma ("DLBCL") in its Territory. HUTCHMED will also participate in Epizyme’s global registrational study of TAZVERIK in combination with R² in second line FL, the EZH-302 study, and lead the study in Greater China. The parties also intend to conduct additional global studies jointly. HUTCHMED will generally be responsible for funding all clinical trials of TAZVERIK in its Territory including the portion of global trials conducted therein. Upon any approvals HUTCHMED will be responsible for commercialization in its designated Territory. HUTCHMED will also hold rights to research and manufacture TAZVERIK in the Territory.

Webcast and Conference Call

Analysts and investors are invited to join a webcast and conference call scheduled today – Monday, August 9 – at 9:30 a.m. Eastern Daylight Time / 2:30 p.m. British Summer Time (BST) / 9:30 p.m. Hong Kong Time (HKT). Investors may participate in the call as follows: +1 646 722 4977 (U.S.) / +44 20 3194 0569 (U.K.) / +852 3027 6500 (Hong Kong), or access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/. Please use participant access code "85770452#."

About Epigenetics, EZH2, Its Role in Cancer and TAZVERIK’s Complementary Role with HUTCHMED’s Portfolio of Drug Candidates

Epigenetics refers to a broad regulatory system that controls gene expression without altering the sequence of the genes themselves. EZH2 is one member of a class of histone methyltransferases ("HMTs"). It catalyzes the methylation of histone H3 at lysine 27 (H3K27) which controls expression of various genes and in turn plays a role in the normal physiology of many cell types.

Dysregulation of EZH2 has been seen in a wide range of cancers and is associated with poor clinical prognosis and outcomes.1,2 It is associated with follicular lymphoma and diffuse large B-cell lymphoma, B-cell malignancies that are estimated to respectively account for approximately 17% and 32% of the estimated 544,000 new cases of non-Hodgkin Lymphoma (NHL) worldwide in 2020.3,4 EZH2 dysregulation has been described in the five most common solid tumors (breast, lung, colorectum, prostate and stomach) with an estimated combined incidence of over 1 million in 2020 globally.

TAZVERIK inhibits EZH2 which allows transcription of genes involved in functions such as cell cycle control and terminal differentiation and thus TAZVERIK action inhibits cancer cell proliferation. This mechanism of action is highly complementary and potentially synergistic with HUTCHMED’s portfolio of cancer drug candidates. For solid tumors, these include fruquintinib, a highly selective inhibitor of vascular endothelial growth factor receptor, and surufatinib, a unique compound that inhibits angiogenesis and promotes the body’s immune response against tumor cells.5 For hematological malignancies, these include many assets including inhibitors of the B-cell signaling pathway such as the highly selective and potent PI3Kδ inhibitor HMPL-689, the Syk inhibitor HMPL-523 and third generation BTK inhibitor HMPL-7606, as well the IDH1/2 inhibitor HMPL-306, the ERK inhibitor HMPL-295, the FGFR inhibitor HMPL-453 and the CD47 antibody HMPL-A83. The potential for broad applicability and favorable safety profile of TAZVERIK may provide more effective inhibition of tumor growth and metastasis when used in combination therapy.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated in the United States 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.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

View the U.S. Full Prescribing Information here: www.Tazverik.com

About TAZVERIK Accelerated Approval in FL

TAZVERIK was approved in the U.S. for the above relapsed/refractory FL indications in June 2020, based on FL cohort efficacy and safety data in a Phase II trial (Study E7438-G000-101, clinicaltrials.gov identifier: NCT01897571).

The efficacy of TAZVERIK was evaluated in an open-label, single-arm, multi-center Phase II clinical trial in patients with histologically confirmed FL whose disease had progressed following at least two prior systemic treatment regimens. Patients were enrolled into two cohorts: one cohort enrolled 45 patients with EZH2 activating mutations and a second cohort enrolled 54 patients with wild-type EZH2. All patients were treated with 800 mg of tazemetostat, administered orally twice a day. The major efficacy outcome measures were ORR and DOR according to the International Working Group Non-Hodgkin Lymphoma (IWG-NHL) criteria (Cheson 2007) as assessed by Independent Review Committee. Median duration of follow-up was 22 months for patients with EZH2 activating mutations and 36 months for patients with wild-type EZH2.

Results of this study were published in The Lancet Oncology.7 Data from the label is below. Among the 45 FL patients with an EZH2 activating mutation who received TAZVERIK, the median age was 62 years (range 38 to 80); 42% were male; 42% had early progression following front-line therapy ("POD24"); and all had an Eastern Cooperative Oncology Group ("ECOG") performance status ("PS") of 0 or 1. The median number of lines of prior systemic therapy was 2.0 (range 1 to 11); 49% were refractory to rituximab and 49% were refractory to their last therapy. In the 42 patients treated with at least 2 prior systemic therapies, the ORR (95% confidence interval) was 69% (53%, 82%), with 12% of patients achieving a complete response and 57% achieving a partial response. The median DOR was 10.9 months and ongoing.

Among the 54 FL patients with wild-type EZH2 who received TAZVERIK, the median age was 61 years (range 36 to 87); 63% were male; 59% had POD24; and 91% had an ECOG PS of 0 or 1. The median number of lines of prior systemic therapy was 3.0 (range 1 to 8); 59% were refractory to rituximab and 41% were refractory to their last therapy. In the 53 patients treated with at least 2 prior systemic therapies, the ORR (95% confidence interval) was 34% (22%, 48%), with 4% of patients achieving a complete response and 30% achieving a partial response. The median DOR was 13.0 months.

Serious adverse reactions, irrespective of attribution, occurred in 30% of patients receiving TAZVERIK. Serious adverse reactions in ≥2% of patients who received TAZVERIK were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Eight patients (8%) discontinued due to adverse reaction during the trial. There were no reported deaths on study, and no black box warnings or contraindications.

The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

EZH-302 is a global, randomized, double-blind, active-controlled, biomarker enrichment, adaptive design Phase Ib/III confirmatory trial (clinicaltrials.gov identifier: NCT04224493) assessing the combination of TAZVERIK with R² (REVLIMID plus rituximab), an approved chemotherapy-free treatment regimen, compared with R² plus placebo for relapsed or refractory FL patients followed by maintenance TAZVERIK or placebo in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients.

About TAZVERIK Accelerated Approval in ES

TAZVERIK was approved in the U.S. for the above ES indication in January 2020, based on ES cohort 5 efficacy and safety data in a Phase II trial (Study EZH-202, clinicaltrials.gov identifier: NCT02601950).

The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort (Cohort 5) of a multi-center study in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients were required to have INI1 loss, detected using local tests, and an ECOG 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 ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR) and DOR. Median duration of follow-up was 14 months (range 0.4 to 31).

Results of this study were published in The Lancet Oncology.8 Data from the label is below. 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.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation.

EZH-301 is a global, randomized, double-blind, placebo-controlled controlled Phase Ib/III confirmatory trial (clinicaltrials.gov identifier: NCT04204941) assessing TAZVERIK in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES. The trial is expected to enroll approximately 150 patients.

About Other TAZVERIK Clinical Development

In addition to the studies in FL and ES, TAZVERIK is also being developed in DLBCL and in prostate cancer and ovarian cancer.