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]).

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!

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).

On October 11, 2024 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies and T-cell engagers, reported the company will be presenting two poster presentations at the upcoming 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024) taking place in Houston, Texas, from November 6-10, 2024, at the George R. Brown Convention Center (Press release, EpimAb Biotherapeutics, OCT 11, 2024, View Source [SID1234648251]).

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 posters will feature: 1) preclinical results for a novel cMet x EGFR bispecific antibody-drug conjugate (ADC) and 2) development and preclinical data for an innovative NK cell engager platform. Details for the presentations are as follows:

cMet x EGFR ADC
Title: A differentiated cMet x EGFR bispecific antibody-drug conjugate demonstrated broad antitumor activity and promising safety profile in preclinical models
Presentation number: 1048
Presentation Date: Saturday, November 9, 2024
Presentation Time: Poster Viewing 12:15-1:45pm CST; Poster Reception 7:10-8:30pm CST (Exhibit Halls AB)

NK Cell Engager Platform
Title: The development of IL15v-NKCE: A cutting-edge NK cell engager platform for cancer treatment
Presentation number: 1078
Presentation Date: Saturday, November 9, 2024
Presentation Time: Poster Viewing 12:15-1:45pm CST; Poster Reception 7:10-8:30pm CST (Exhibit Halls AB)

On October 11, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy (Press release, Foundation Medicine, OCT 11, 2024, View Source [SID1234647160]).

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!

Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative.1 PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation.2

"This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first-line setting for metastatic breast cancer patients," said Mia Levy, Ph.D., M.D., chief medical officer at Foundation Medicine. "Our high-quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. From a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With this approval, Foundation Medicine has seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company.3 Foundation Medicine is the global leader in approved companion diagnostic indications with more than 60% of all approved U.S. companion diagnostic indications for next-generation sequencing (NGS) testing.

"Given the high prevalence of PIK3CA mutations in hormone receptor-positive, HER2-negative breast cancer, the introduction of a new targeted treatment regimen in the first-line setting will have a profound impact on this patient population," said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. "Biomarker testing plays an important role in helping patients and their families make personalized treatment decisions based on their individual cancer, and we’re encouraged to see Foundation Medicine continue to expand its approved companion diagnostic indications in breast cancer."