On August 7, 2022 ImmVira reported that it’s brand new oncolytic herpes simplex virus ("oHSV") product MVR-C5252 targeting Malignant Glioma has obtained Orphan Drug Designation ("ODD") from U.S. Food and Drug Administration ("FDA") (Press release, Immvira, AUG 7, 2022, View Source [SID1234617721]).

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Malignant glioma has been a special challenge for patients and healthcare professionals for a long time, with limited treatment options including surgical resection, chemotherapy, and/or radiation therapy. The prognosis for the disease also remains poor, with median overall survival ("OS") varying between 12 – 14 months, a 5-year survival ranging from 4% to 5% and a nearly 100% relapse rate, representing a huge unmet medical need.

Developed on ImmVira’s OvPENS new drug development platform, MVR-C5252 is designed specifically for the treatment of glioma by specific attenuation to achieve on-target malignant gliocyte killing while maintaining safety profile. MVR-C5252 is also the only oncolytic virus product targeting brain tumors that carries specific exogenous genes to promote the immune response of tumor microenvironment and achieve optimal anti-tumor activity. MVR-C5252 has obtained IND clearance from the U.S. FDA and is currently under preparation for Phase I clinical study.

FDA enacted the Orphan Drug Act to encourage and provide special incentives to pharmaceutical companies that undertake the responsibility of developing orphan drugs that target diseases affecting fewer than 200,000 people in the United States. The ODD status will further accelerate the clinical development and registration of MVR-C5252 in the United States, and will also allow MVR-C5252 to enjoy exclusive marketing and development rights and other benefits, such as protocol assistance from FDA, potential decreased wait-time for drug approval, discounts on certain fees, and eligibility for seven years of market exclusivity in the United States, etc.

Dr. Grace Guoying Zhou, ImmVira’s Chairwoman and CEO, said, "ODD status granted by FDA to MVR-C5252 means a lot for glioma patients, and also demonstrated FDA’s recognition for this product and company’s clinical development and registration capability as well. ImmVira will continue to advance the clinical development of MVR-C5252 in both U.S. and China, promote the early launch of the candidate product to save more patients’ lives."

On August 7, 2022 Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") reported the completion of first patient dosing in the U.S. Phase I clinical trial of ASC61, an oral PD-L1 small molecule inhibitor prodrug, for treatment of advanced solid tumors (Press release, Ascletis, AUG 7, 2022, View Source [SID1234617722]).

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This U.S. Phase I trial is a dose-escalation study to evaluate the safety and tolerability of ASC61 as well as to define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ASC61 in patients with advanced solid tumors who have disease progression during or following standard therapy.

ASC61 is an oral small molecule inhibitor prodrug. Its active metabolite, ASC61-A, is a potent and highly selective inhibitor which blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models including humanized mouse model. Preclinical studies showed that ASC61 has good safety and pharmacokinetic profiles in animal models. ASC61 oral tablets used in the clinical trial, were developed with the in-house proprietary technology of Ascletis.

In a head-to-head comparison study using the human PD-L1 expressing cells and fresh peripheral blood mononuclear cells (PBMCs) co-culture assay, ASC61-A treatment induced secretion of IFNγ in a concentration dependent manner, with an EC50 of 2.86 nM. Maximal levels of IFNγ induced by ASC61-A were similar to that induced by Keytruda.

Compared with PD-1/PD-L1 antibody injections, the oral PD-L1 inhibitor ASC61 has the following benefits: (1) higher patient compliance with easy and safe administration with no need of hospital visits for injections; (2) ease of all oral combination therapies with other oral anti-tumor drugs; (3) easier to manage immune-related adverse effects (irAEs) with dose adjustment; (4) relatively lower cost; and (5) higher permeability to distribute into targeted tissues.

"Immunogenicity and the poor permeability of tumor tissues are the major disadvantages of therapeutic antibodies, which can cause a low response rate of PD-1/PD-L1 antibodies. As a highly differentiated small molecule PD-L1 inhibitor, ASC61 has several advantages over antibodies, and showed promising preliminary efficacy and safety profile in preclinical studies. This progress of ASC61 on advanced solid tumors further demonstrated Ascletis’ global R&D capability and execution. We expect to further advance the studies on ASC61 to provide more options for patients with advanced solid tumors." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

On August 7, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported the presentation of the final progression-free survival (PFS) analysis results from the registrational GEMSTONE-301 study of sugemalimab as a consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease had not progressed after concurrent or sequential chemoradiotherapy at the IASLC 2022 World Conference on Lung Cancer (WCLC) (Press release, CStone Pharmaceauticals, AUG 7, 2022, View Source [SID1234617723]). The data showed sugemalimab maintained a statistically significant and clinically meaningful improvement in the PFS as assessed by blinded independent central review (BICR). Subgroup analysis demonstrated clinical benefits in patients who had received either concurrent or sequential chemoradiotherapy prior to sugemalimab.

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The GEMSTONE-301 study is a multicenter, randomized, double-blind phase 3 clinical trial, designed to evaluate the efficacy and safety of sugemalimab as a consolidation therapy in patients with unresectable stage III NSCLC whose disease had not progressed after concurrent or sequential chemoradiotherapy. In May 2021, the GEMSTONE-301 study met its primary endpoint at pre-planned interim analysis. The findings showed that sugemalimab demonstrated a statistically significant and clinically meaningful improvement in PFS as compared to placebo. Subgroup analyses demonstrated that sugemalimab was associated with clinical benefits regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab.

The results presented at the WCLC 2022 were based on the PFS final analysis data. As of March 1, 2022, key results of this study are the following:

BICR-assessed median PFS: 10.5 months for sugemalimab vs 6.2 months for placebo (HR= 0.65, 95% CI 0.50–0.84)
– For patients who received sequential chemoradiotherapy: the median PFS was 8.1 months vs 4.1 months, HR=0.57

– For patients who received concurrent chemoradiotherapy: the median PFS was 15.7 months vs 8.3 months, HR=0.71

Preliminary overall survival data showed a trend for benefit favoring sugemalimab, median overall survival (OS): not reached for sugemalimab vs 25.9 months for placebo (HR= 0.69, 95% CI 0.49-0.97)
– For patients who received sequential chemoradiotherapy: the median OS was not reached vs 24.1 months, HR=0.60

– For patients who received concurrent chemoradiotherapy: the median OS was not reached vs 32.4 months, HR=0.75

Similar objective response rate (ORR) was seen between sugemalimab and placebo but duration of overall response (DoR) was longer with sugemalimab
– ORR: 24.5% vs 25.2%

– DoR: 24.1 months vs 6.9 months

Sugemalimab had a well-tolerated safety profile; no new safety signals were observed in PFS final analysis
Professor Yi-Long Wu, a tenured director of Guangdong Provincial People’s Hospital, and the Leading Principal Investigator on the GEMSTONE-301 study, said, "The final PFS results from GEMSTONE-301 showed that sugemalimab as a consolidation therapy demonstrated PFS and OS benefits in patients with unresectable stage III NSCLC following concurrent or sequential chemoradiotherapy. The overall benefit was consistent with that in the PACIFIC study. Sugemalimab could be safely and effectively used after concurrent or sequential chemoradiotherapy and become a standard of care in this setting for unresectable stage III NSCLC. Sugemalimab has been approved in China for the treatment of patients with stage III NSCLC and recommended by 2022 Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines for Primary NSCLC as a preferred treatment option."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are delighted that the updated results of GEMSTONE-301 are presented at WCLC 2022 and highlighted in the press conference session. In the final PFS analysis, sugemalimab demonstrated clinical benefits in patients receiving either concurrent or sequential chemoradiotherapy, while preliminary OS benefits were also observed. The interim PFS data has been published in the journal of The Lancet Oncology. We are working with our partner to engage regulatory agencies worldwide and to bring sugemalimab to more cancer patients with its robust efficacy and safety profile."

About the GEMSTONE-301 study

The GEMSTONE-301 study (clinicaltrials.gov registration number: NCT03728556; drug clinical trial registration number: CTR20181429) is a multicenter, randomized, double-blind phase 3 clinical trial, designed to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC whose disease had not progressed following concurrent or sequential chemoradiotherapy. The trial’s primary endpoint was PFS as assessed by BICR according to RECIST v1.1; the secondary endpoints included OS, PFS as assessed by investigators and safety.

In May 2021, the GEMSTONE-301 study met its primary endpoint at a pre-planned interim analysis reviewed by the iDMC. The findings showed that sugemalimab demonstrated statistically significant and clinically meaningful improvement in the BICR assessed PFS. Investigator-assessed PFS showed consistent results as those of the primary endpoint. Sugemalimab was well tolerated with no new safety signals. Subgroup analyses demonstrated that sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab. The data were reported in the late-breaking abstract (LBA) presentation at the 2021 ESMO (Free ESMO Whitepaper) Annual Meeting and published in The Lancet Oncology in January 2022.

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may allow a reduced the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

Currently, the National Medical Products Administration of China has approved sugemalimab (Cejemly):

In combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, lacking EGFR and ALK genomic tumor aberrations; and in combination with paclitaxel and carboplatin as first-line treatment of patients with metastatic squamous NSCLC
For the treatment of patients with unresectable stage III non-small cell lung cancer whose disease had not progressed following concurrent or sequential platinum-based chemoradiotherapy
With its proven therapeutic advantages, sugemalimab is recommended by the 2022 Chinese Society of Clinical Oncology (CSCO) clinical guidelines for the diagnosis and treatment of NSCLC, in combination with chemotherapy as the first-line treatment of patients with stage IV non-squamous/squamous NSCLC without driver alterations; or as a consolidation therapy in patients with stage III NSCLC following concurrent or sequential platinum-based chemoradiotherapy.

CStone formed a strategic collaboration agreement with EQRx, under which EQRx licensed the exclusive rights to sugemalimab for development and commercialization outside of Greater China.

On August 7, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the appointment of Dr. Caroline Germa as the company’s Executive Vice President, Global Medicine Development and Chief Medical Officer, reporting to Dr. Xueming Qian, CEO (Press release, Transcenta, AUG 7, 2022, View Source [SID1234617725]). Dr. Germa will be primarily responsible for leading the global development and translational research teams to advance Transcenta’s pipeline molecules, conducting registrational trials to enable for approval by multiple global regulatory agencies, ensuring safety and compliance, as well as leading the global clinical collaborations with existing and potential partners.

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Dr. Caroline Germa is an accomplished medical oncologist and medicine development leader with over 20 years of pharmaceutical experience, across the spectrum of drug development, from early clinical trials to late phase and registration.

Prior to joining Transcenta, Dr. Germa served as the Vice President and Head of the Early Development Clinical Group for AstraZeneca oncology department. During her time at AstraZeneca, Dr. Germa built an Early Development Clinical Group with over 180 staff and guided the clinical development of the early oncology portfolio.

Immediately prior to joining AstraZeneca, she worked for Bristol Myers Squibb ("BMS") and served as the Vice President of BMS Oncology and Development Team Lead for a major partnered oncology program.

Before Joining BMS, Dr. Germa spent seven years at Novartis, and led the late phase clinical development of multiple key oncology assets, especially the worldwide registration strategy and approval of Ribociclib (CDK4/6 inhibitor – Kisqali).

Earlier in her career, she also worked for Pfizer as its clinical lead for Neratinib (anti-HER2 inhibitor, Nerlynx) as well as Eli Lilly France and Sanofi/Aventis.

Dr. Germa received her MD and Medical Oncologist Degree, as well as Breast Disease and Immunology Master Degrees from Paris and Lille University, France.

"I would like to express my warmest welcome to Dr. Germa on her appointment," said Dr. Xueming Qian, CEO of Transcenta. "With her outstanding capabilities in global clinical development of innovative medicines and regulatory approval achievements, strong organizational leadership and rich management experience, as well as academic excellence in oncology, we believe that Dr. Germa will bring strong leadership to Transcenta for our global expansion, lead global development and regulatory approval of our innovative lead clinical assets, and make great contributions to increase the shareholder value of Transcenta."

"Delivering meaningful treatment options to patients is what drives me. I am thrilled to join Transcenta at this important juncture," said Dr. Caroline Germa, Executive Vice President, Global Medicine Development and Chief Medical Officer of Transcenta. "The early clinical data for TST001 are very promising and I look forward to working alongside Transcenta highly skilled scientific teams to bring the whole Transcenta portfolio to patients globally."

On August 6, 2022 AstraZeneca and Daiichi Sankyo reported it’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy (Press release, AstraZeneca, AUG 6, 2022, View Source [SID1234622253]).

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Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by the Food and Drug Administration (FDA) was based on the results from the DESTINY-Breast04 Phase III trial. In the trial, Enhertu reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy in patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive disease or HR-negative disease (median progression-free survival [PFS] 9.9 versus 5.1 months; hazard ratio [HR] 0.50; 95% confidence interval [CI] 0.40-0.63; p<0.0001). A median overall survival (OS) of 23.4 months was seen in patients treated with Enhertu versus 16.8 months in those treated with chemotherapy, a 36% reduction in the risk of death (HR 0.64; 95% CI 0.49-0.84; p=0.001).

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, US, said: "Approximately half of all patients with breast cancer have tumours that are HER2-low, which have previously been classified as HER2-negative and have not had effective treatment options with HER2-targeted medicines. Based on the promising results of the DESTINY-Breast04 trial, clinicians are starting to differentiate levels of HER2 expression and redefine how metastatic breast cancer is classified with a distinct HER2-low patient population that may be eligible for trastuzumab deruxtecan."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "The rapid approval of Enhertu in HER2-low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible. Patients with HER2-low tumours, who are identified through existing HER2 testing methods, will now have the opportunity to be treated based upon their HER2 status."

Ken Keller, Global Head of Oncology Business and President and CEO, Daiichi Sankyo, Inc, said: "Today’s FDA approval marks a monumental moment in breast cancer treatment as Enhertu is the first-ever HER2-directed medicine to be approved for the treatment of patients with HER2-low metastatic breast cancer. With the ground-breaking survival benefit seen in the DESTINY-Breast04 trial, this milestone confirms the importance of targeting lower levels of HER2 expression in the treatment of metastatic breast cancer and we are thrilled that we can now offer Enhertu to even more patients."

The approval was granted under the FDA’s Real-Time Oncology Review programme after securing Priority Review and Breakthrough Therapy Designation of Enhertu in the US in this setting. The expanded approval for Enhertu in the US, following its previous approval in 2nd-line HER2-positive metastatic breast cancer, enables its use across a wide spectrum of HER2-expressing breast cancer, including patients with HER2-low disease.

The DESTINY-Breast04 Phase III trial results were presented at the presidential plenary session of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting and simultaneously published in The New England Journal of Medicine (NEJM).1

The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) or pneumonitis rates were consistent with those observed in late-line HER2-positive breast cancer trials of Enhertu. Overall, 12% of patients had confirmed ILD or pneumonitis related to treatment as determined by an independent adjudication committee. The majority of ILD events were Grade 1 or 2 (10%), with five Grade 3 (1.3%) and no Grade 4 events reported. There were three (0.8%) ILD-related deaths (Grade 5).

In June 2022, fam-trastuzumab deruxtecan-nxki (Enhertu) was added to the NCCN Clinical Practical Guidelines in Oncology (NCCN Guidelines) as the Category 1 preferred regimen for patients with tumours that are HER2 IHC 1+ or 2+ and ISH- who have received at least one prior line of chemotherapy for metastatic disease and, if tumour is HR-positive, are refractory to endocrine therapy, based on the data from DESTINY-Breast04.2

The US regulatory submission for DESTINY-Breast04 was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, Enhertu is also under regulatory review for the same indication by the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency (ANVISA), Health Canada and Switzerland’s Swissmedic.

Regulatory applications for Enhertu are also currently under review in Europe, Japan and several other countries based on the DESTINY-Breast04 results.

Notes

Financial considerations
Following this approval for Enhertu in the US, an amount of $200m is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2-low breast cancer post chemotherapy indication. The milestone will be capitalised as an addition to the upfront payment made by AstraZeneca to Daiichi Sankyo in 2019 and subsequent capitalised milestones, and will be amortised through the profit and loss statement.

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as collaboration revenue in the Company’s financial statements.

Further details on the financial arrangements were set out in the March 2019 announcement of the collaboration.

Breast cancer and HER2 expression
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the US.3,4 More than two million patients with breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.3 In the US, more than 290,000 patients are expected to be diagnosed in 2022, resulting in more than 43,000 deaths.5

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, and is one of many biomarkers expressed in breast cancer tumours.6

HER2 expression is currently determined by an immunohistochemistry (IHC) test which estimates the amount of HER2 protein on a cancer cell, and/or an in-situ hybridisation (ISH) test, which counts the copies of the HER2 gene in cancer cells.6,7 HER2 tests provide IHC and ISH scores across the full HER2 spectrum and are routinely used to determine appropriate treatment options for patients with metastatic breast cancer.

HER2-positive cancers are currently defined as HER2 expression measured as IHC 3+ or IHC 2+/ISH+, and HER2-negative cancers are defined as HER2 expression measured as IHC 0, IHC 1+ or IHC 2+/ISH-.6 However, approximately half of all breast cancers are HER2-low, defined as an HER2 score of IHC 1+ or IHC 2+/ISH-.8-10 HER2-low occurs in both HR-positive and HR-negative disease.11

Previously, patients with HR-positive metastatic breast cancer and HER2-low disease had limited effective treatment options following progression on endocrine (hormone) therapy.9,12 Additionally, few targeted options were available for those with HR-negative disease.13 Now with the approval of Enhertu, patients with HER2-low tumours may be eligible for HER2-directed therapy.

DESTINY-Breast04
DESTINY-Breast04 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive or HR-negative, HER2-low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomised 2:1 to receive either Enhertu or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomised patients (HR-positive and HR-negative disease), OS in patients with HR-positive disease and OS in all randomised patients (HR-positive and HR-negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North 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 more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in several countries 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 based on the results from the DESTINY-Breast01 trial.

Enhertu (5.4mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (6.4mg/kg) is approved in several countries 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.

Regulatory applications for Enhertu in breast, gastric and non-small cell lung cancer are currently under review in several other countries based on the DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01, DESTINY-Gastric02 and DESTINY-Lung01 trials, respectively.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as 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 the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging and redefining the current clinical paradigm for how breast cancer is classified and treated to deliver even more 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 selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in HER2-negative early and 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 initial approvals 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, evaluating 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.