On October 14, 2024 AstraZeneca and Daiichi Sankyo’s reported that Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy (Press release, AstraZeneca, OCT 14, 2024, View Source [SID1234647178]).

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The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval for this indication will depend on the clinical benefit of a confirmatory trial.

Each year in China, more than one million people are diagnosed with lung cancer, accounting for more than 40% of the world’s lung cancer patients – the majority are diagnosed with advanced disease.1,2,3 Approximately 2% to 4% of patients with NSCLC have tumours with activating HER2 mutations.4,5

Ying Cheng, MD, PhD, Director of Jilin Lung Cancer Centre, China, and principal investigator of DESTINY-Lung05, said: "While there have been many advancements in the treatment of non-small cell lung cancer in China in recent years, patients with HER2-mutant disease have had few treatment options and none directed towards this specific type of lung cancer. This approval of Enhertu offers an important new targeted treatment for patients with this aggressive form of disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "This approval of Enhertu represents the first HER2-directed therapy approved in China for the treatment of HER2-mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. It also reinforces the importance of testing for predictive biomarkers in lung cancer at the time of diagnosis, including HER2 mutations, to ensure patients can receive the most appropriate treatment for their specific disease."

Kiminori Nagao, Head of the Asia, South & Central America Business Unit, Daiichi Sankyo, said: "Since our initial approval of Enhertu for patients with HER2-positive metastatic breast cancer in China last year, we have remained committed to bringing this innovative antibody drug conjugate to more patients in China, especially those that have previously not been eligible for treatment with a HER2-directed therapy. Today’s milestone marks the fourth approval of Enhertu in China and follows the recent approval for HER2-positive metastatic gastric cancer, reinforcing its benefit across multiple HER2-targetable tumours."

In DESTINY-Lung02, which included patients from Japan, Korea and Taiwan (China), patients with previously treated HER2-mutant metastatic NSCLC treated with Enhertu (5.4mg/kg) showed a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI] 39.0-59.1), as assessed by blinded independent central review (BICR). Median duration of response (DoR) was 16.8 months (95% CI 6.4-non-evaluable [NE]). Median progression-free survival (PFS) was 9.9 months (95% CI 7.4-NE) and median overall survival (OS) was 19.5 months (95% CI 13.6-NE).

In DESTINY-Lung05, Enhertu (5.4mg/kg) demonstrated a consistent clinically meaningful response in patients in China with previously treated HER2-mutant metastatic NSCLC. Treatment with Enhertu resulted in a confirmed ORR of 58.3% (95% CI 46.1-69.8), as assessed by independent central review (ICR).

The safety profile of Enhertu in DESTINY-Lung02 and DESTINY-Lung05 were similar and generally consistent with previous clinical trials of Enhertu in lung cancer with no new safety concerns identified.

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

Enhertu is already approved for the treatment of previously treated unresectable or metastatic HER2-mutant NSCLC in more than 45 countries, including the US, Japan and across the EU.

Notes

HER2-mutant NSCLC
Lung cancer is the most common form of cancer globally in both men and women.2 Each year there are approximately 2.5 million people diagnosed with lung cancer globally, with 80-85% diagnosed with NSCLC.2,6 Prognosis is poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis.7

In China, lung cancer is the most commonly diagnosed cancer with more than one million cases diagnosed in 2022.1 It is also the leading cause of cancer-related deaths in China, with more than 733,000 deaths reported in 2022.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumour types. Certain HER2 (ERBB2) gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2% to 4% of patients with this type of lung cancer.4,5 While HER2 gene mutations can occur in a range of patients, they are more commonly found in patients with NSCLC who are younger, female and have never smoked.8 HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.9 Next-generation sequencing has been utilised in the identification of HER2 (ERBB2) mutations.10

DESTINY-Lung02
DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of Enhertu in patients with HER2-mutant unresectable and/or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy. Patients were randomised 2:1 to receive Enhertu 5.4mg/kg (n=102) or Enhertu 6.4mg/kg (n=50).

The primary endpoint of the trial is confirmed ORR as assessed by BICR. Secondary endpoints include disease control rate (DCR), DoR and PFS assessed by investigator and BICR, OS and safety.

DESTINY-Lung02 enrolled 152 patients at multiple sites, including Asia, Europe, Oceania and North America. For more information about the trial, visit clinicaltrials.gov.

DESTINY-Lung05
DESTINY-Lung05 is an open-label, single-arm Phase II trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) in patients with HER2-mutant metastatic NSCLC with disease progression on or after at least one prior anticancer therapy.

The primary endpoint of the trial is confirmed ORR as assessed by ICR. Secondary endpoints include investigator-assessed confirmed ORR, as well as ICR and investigator-assessed DoR, DCR, PFS and safety.

DESTINY-Lung05 enrolled 72 patients at multiple sites in China. 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 number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) 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 more than 65 countries worldwide 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 systemic therapy 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 (5.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu (5.4mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.

Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and 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 delver 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 October 13, 2024 Akeso Biopharma (9926. HK) ("Akeso", the "Company" ) reported that it has successfully raised approximately $250 million USD through a share placement (Press release, Akeso Biopharma, OCT 13, 2024, View Source [SID1234656029]). This offering has earned notable recognition among international investment firms, with the majority of our final subscribers being long-term funds and healthcare funds.

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This marks Akeso’s second successful share placement in 2024. Following this transaction, the Company’s cash on hand is expected to be 1.064 billion USD (7.5 billion RMB).

Seventy percent of the financing will be allocated to accelerating the global clinical development of innovative drugs developed internally by Akeso, with a primary focus on its core products in both China and international markets.

Dr. Xia Yu, Founder, Chairwoman, President, and Chief Executive Officer of Akeso Biopharma, stated: "The efficient completion of this share placement reflects Akeso’s long-term investment value being highly recognized by international long-term institutional investors and specialized institutions in the healthcare sector. The success of this financing will bolster Akeso’s global development strategy for a diversified pipeline of independently developed new drugs, particularly by accelerating multi-center international clinical trials led by Akeso. This initiative will enhance the global value exploration of our internally developed new drugs and further strengthen our competitiveness in the international market."

On October 13, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies (Press release, Dizal Pharma, OCT 13, 2024, View Source [SID1234647171]).

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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

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This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.

BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).

"The total of four Breakthrough Therapy Designations by both the U.S. and China’s regulatory agencies, reflects not only sunvozertinib’s transformative potential in EGFR exon20ins NSCLC, but also Dizal’s commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."

The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.

NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on WU-KONG6 study results. In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Dizal revealed its WU-KONG1 Part B study results, a multinational study with patients from Asia, Europe, North America, and South America. The study met its primary endpoint. Regulatory submissions for market approvals are ongoing.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

On October 13, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies (Press release, Dizal Pharma, OCT 13, 2024, View Source [SID1234647171]).

This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.

BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).

"The total of four Breakthrough Therapy Designations by both the U.S. and China’s regulatory agencies, reflects not only sunvozertinib’s transformative potential in EGFR exon20ins NSCLC, but also Dizal’s commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."

The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.

NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on WU-KONG6 study results. In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Dizal revealed its WU-KONG1 Part B study results, a multinational study with patients from Asia, Europe, North America, and South America. The study met its primary endpoint. Regulatory submissions for market approvals are ongoing.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).

On October 13, 2024 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for sunvozertinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) who have not received prior systemic therapies (Press release, Dizal Pharma, OCT 13, 2024, View Source [SID1234647171]).

This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the U.S. FDA and the China CDE for relapsed or refractory patients.

BTD procedures in the US and China are designed to expedite the development and regulatory review of new medicines that are intended to treat serious or life-threatening conditions with preliminary clinical evidence indicating substantial improvement over available therapies. Drug candidates with BTD can be considered for priority review when submitting a New Drug Application (NDA).

"The total of four Breakthrough Therapy Designations by both the U.S. and China’s regulatory agencies, reflects not only sunvozertinib’s transformative potential in EGFR exon20ins NSCLC, but also Dizal’s commitment to developing groundbreaking new medicines to address unmet medical needs globally." said Xiaolin Zhang, PhD, CEO of Dizal, "Sunvozertinib is the world first and only oral drug approved for the treatment of lung cancer patients with EGFR exon20ins. We are accelerating ongoing clinical studies and regulatory submissions, hoping to bring this new treatment option to more patients as quickly as possible."

The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from China. Results from these studies showed that sunvozertinib, as a single oral agent, produced a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. Additionally, sunvozertinib is well tolerated with overall safety profile similar to classic EGFR-TKIs.

Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.

NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.

Sunvozertinib was approved in China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins in 2023 based on WU-KONG6 study results. In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Dizal revealed its WU-KONG1 Part B study results, a multinational study with patients from Asia, Europe, North America, and South America. The study met its primary endpoint. Regulatory submissions for market approvals are ongoing.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).