On June 1, 2025 InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, reported latest clinical data from a Phase Ib/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS G12C mutant solid tumors (Press release, InxMed, JUN 1, 2025, View Source;kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025-302470109.html [SID1234653570]).

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The clinical data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #8629 | Poster Board #109) included results from two cohorts:

Durability follow-up data of the single-arm cohort in first-line KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.
A randomized cohort in previously treated KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy.
In NSCLC cohort, the combination of ifebemtinib and garsorasib, as a dual-oral, chemotherapy-free regimen, demonstrated compelling clinical benefit including high response rates and durable efficacy, regardless of PD-L1 expression, and in CRC cohort, the result showed clear add-on efficacy by ifebemtinib compared to KRAS inhibitor monotherapy.

Key Highlights in First-line NSCLC: Dual-Oral Regimen Shows Durable Efficacy and Emerging Survival Benefit

As of March 31, 2025, 33 first-line NSCLC patients, regardless of PD-L1 expression, were enrolled and received the combination of ifebemtinib and garsorasib, with a median follow-up of 16.0 months. Previously the company has reported an Objective Response rate (ORR) of 90.3% (data presented at ESMO (Free ESMO Whitepaper) 2024). The follow-up data were now summarized as follows:

Median progression-free survival (mPFS): 22.3 months
Median duration of response DOR (mDOR): 19.4 months
Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.
Of note, the treatment demonstrated consistent efficacy regardless of PD-L1 expression status.

Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci

As of Apr 21, 2025, 36 previously treated CRC patients were randomized 1:1 to receive the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:

ORR: 44.4% (combo) vs. 16.7% (mono)
Disease control rate (DCR): 100.0% (combo) vs. 77.8% (mono)
mPFS: 7.7 months (combo) vs. 4.0 months (mono)
mOS: not yet reached in the combination arm; early separation observed in the survival curves
"These results validate ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly," said Dr. Zaiqi Wang, Chief Executive Officer of InxMed. "The unprecedented 19-month DOR and 22-month median PFS in front-line NSCLC in all comers and near doubling of response rate in CRC position this dual-oral regimen as a potential paradigm shift treatment in KRAS G12C-mutant cancers. Its favorable safety profile further supports the potential for a cytotoxic chemotherapy-free regimen in winning front-line in the future."

InxMed has initiated a randomized Phase III pivotal trial in first-line KRAS G12C-mutant NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including KRAS G12D inhibitors and multi-RAS inhibitors, supported by promising preclinical synergy data.

About Ifebemtinib (IN10018)

Ifebemtinib (IN10018) is a highly selective, orally administered, small molecule inhibitor against FAK, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, it has demonstrated therapeutic synergies with chemotherapy, targeted therapies, and immunotherapies. To date, over 600 patients have been treated with a favorable safety and tolerability profile.

Ifebemtinib has been granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track Designation from the U.S. Food and Drug Administration (FDA). A New Drug Application submission to the NMPA is planned for 2025.

On June 1, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ("satri-cel", CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Carsgen Therapeutics, JUN 1, 2025, View Source [SID1234653569]). Further details have been posted on the corporate website View Source

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The article in The Lancet was titled "Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial". Full article available at: View Source(25)00860-8.

The oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract 4003) was titled "Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)".

Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, "The CT041-ST-01 trial represents the world’s first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel’s potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients’ survival, and ultimately pursue potential cures."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team’s years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world’s first commercially available CAR-T product for solid tumors, bringing benefits to patients."

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).

Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.

On June 1, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") reported the presentation of groundbreaking clinical data from a multicenter phase Ib/II clinical trial evaluating LBL-024, an anti-PD-L1/4-1BB bispecific antibody, in combination with etoposide plus platinum-based chemotherapy for treatment-naive patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) (Press release, Nanjing Leads Biolabs, JUN 1, 2025, View Source [SID1234653568]). The results were featured in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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ASCO is recognized as the world’s most prestigious oncology conference, serving as a global stage for unveiling transformative scientific and clinical advancements. The Oral Sessions are highly competitive, served for studies demonstrating significant clinical relevance or scientific innovation. In 2025, ASCO (Free ASCO Whitepaper) received a record-breaking 7,775 abstract submissions, with 32 Chinese-led studies selected for oral presentation – among them, the LBL-024 trial (NCT06157827).

The study, led by Professor Shen Lin of Peking University Cancer Hospital and conducted across multiple clinical centers, evaluates the efficacy and safety of LBL-024 combined with etoposide plus platinum-based chemotherapy as a first-line treatment for advanced EP-NEC.

Robust Anti-Tumor Activity Observed with LBL-024 Plus Chemotherapy

In 52 efficacy-evaluable patients, the overall response rate (ORR) across all dose levels was 75.0% and the disease control rate (DCR) was 92.3%, significantly outperforming historical ORR data (30%-55%) with chemotherapy alone.
The 15 mg/kg in dose optimization demonstrated the strongest anti-tumor activity, achieving an ORR of 83.3% and a DCR of 100%.
57.7% (30/52) of the patients experienced >50% tumor shrinkage.
As of April 15th, 2025, with a median follow-up of 8.2 months, progression-free survival (PFS) data remains immature, but trends indicate promising durability across all the dose groups.
In the phase Ib dose escalation stage, no dose-limiting toxicities (DLTs) were observed. Most treatment-emergent adverse events (TEAEs) were Grade 1–2 and manageable, primarily associated with chemotherapy, including hematologic toxicity and nausea. No unexpected safety signals were identified.
Leadership Perspectives

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:" We are thrilled to share these exciting clinical data, which strongly support the advancement of LBL-024 into a pivotal phase III trial as a first-line treatment for EP-NEC. Our strategy prioritizes efficient development through single-arm registrational trial in underserved indications, while also maximizing value through broad indication expansion. LBL-024 received regulatory clearance in April 2024 to initiate a single-arm pivotal trial in China, marking the first 4-1BB targeted agent globally to reach this stage. With its expanded use now demonstrated in first-line settings and active studies in cancers such as SCLC and NSCLC, LBL-024 is poised to offer promising transformative therapeutic options for more cancer patients worldwide."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "It is deeply encouraging to see LBL-024 featured consecutively in ASCO (Free ASCO Whitepaper) oral presentations. From target selection to molecular design, our R&D approach has focused on differentiated innovation to address pressing clinical challenges. The success of LBL-024 reflects our commitment to pioneering innovation at the source—breaking free from homogeneity to deliver genuinely impactful therapies. We remain dedicated to addressing unmet needs, advancing breakthrough therapeutics, and improving outcomes for patients across the globe."

About LBL-024

LBL-024 is a potential first-in-class bispecific antibody simultaneously targeting PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to reach the single arm pivotal trial stage as a monotherapy and holds promise to become the first approved treatment specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC), a malignancy with significant unmet medical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, LBL-024 features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows LBL-024 to both reverse PD-L1–mediated immune suppression and selectively enhance T cell activation, resulting in potent, synergistic anti-tumor effects.

In Phase I/II clinical trials in China, LBL-024 has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. The lack of a standard of care in EP-NEC supports the pursuit of accelerated approval through a single-arm pivotal study.

In recognition of its clinical potential, LBL-024 received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China (October 2024), and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for neuroendocrine carcinoma (November 2024).

Beyond NEC, LBL-024 has shown encouraging early activity in other tumor types, including small cell lung cancer (SCLC), ovarian cancer (OC), biliary tract cancer (BTC), and with strong potential for expansion into broader indications such as non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC).

On June 1, 2025 Johnson & Johnson reported new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body’s immune system against prostate cancer cells, showing promise in patients with advanced disease who have progressed after multiple lines of therapy (Press release, Johnson & Johnson, JUN 1, 2025, View Source;johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer-302470142.html [SID1234653567]). These first data on pasritamig, from the first-in-human study, demonstrate that pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC), highlighting the potential of KLK2 as a novel target for T-cell engagement in advanced disease.1 These data were presented as an oral presentation (Abstract #5017) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published simultaneously in The Journal of Clinical Oncology.

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Pasritamig is a novel T-cell engager designed to bind both CD3 on T-cells and KLK2—a prostate-specific antigen with minimal expression outside of the prostate. Pasritamig activates T-cells by binding to CD3 and directing them to KLK2- expressing tumor cells, engaging the body’s immune system to specifically target these cancerous cells. This differentiated approach aims to deliver a targeted treatment for patients with advanced prostate cancer, while potentially reducing the high-grade toxicities historically associated with T-cell engagers.

"These first-in-human results for pasritamig are highly encouraging, demonstrating that KLK2 is a viable target for T-cell engagers in metastatic castration-resistant prostate cancer," said Capucine Baldini*, M.D., Ph.D., Drug Development Department (DITEP), Institut Gustave Roussy, and presenting author. "The data show a promising safety profile, with manageable adverse events and no AEs leading to treatment discontinuations or ICANS observed, with 40 percent of patients having no treatment-related AEs at all. Given the limited treatment options for mCRPC, these findings support further investigation of pasritamig and the role of KLK2-targeted T-cell therapies as a potential new approach for patients with aggressive disease."

"Metastatic castration-resistant prostate cancer remains one of the most difficult stages of prostate cancer to treat, particularly for patients who haven’t responded well to previous treatments," said Jeff Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. "This investigational approach underscores our commitment to developing innovative and practice-changing medicines that are well-tolerated and can be easily administered in community practice settings."

The Phase 1 first-in-human study (NCT04898634) evaluated 174 patients with ages ranging from 36 to 89 years old and on average having received four prior therapies (range 1-13). The recommended phase 2 dose (RP2D) of pasritamig was 3.5mg on day 1, 18mg on day 8, 300mg intravenously on day 15 and then once every six weeks. The RP2D safety group also included patients treated once every three weeks as the toxicity profiles were very similar. The RP2D efficacy group only included patients treated at the RP2D once every six weeks.1

Within the RP2D safety group (n=45), treated once every three or six weeks, 100 percent had previously received androgen receptor pathway inhibitors, 75.6 percent had undergone taxane chemotherapy, and 37.8 percent had been treated with Lutetium 177 vipivotide tetraxetan prostate-specific membrane antigen radioligand therapy.1 The most common treatment- related adverse events (TRAEs) were Grade 1/2 infusion-related reactions (24.4 percent), Grade 1 cytokine release syndrome (CRS) presenting as fever only (8.9 percent, no steroid or tocilizumab was administered) and no reports of higher grade CRS. No TRAEs leading to treatment discontinuation or dose reduction were reported and no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Grade 3 TRAEs were infrequent with 4.4 percent of patients reporting transient AST/ALT increases and neutropenia. There were no dose-limiting toxicities reported. The favorable safety profile of the RP2D regimen enabled convenient outpatient administration on a patient-friendly, once-every-six-weeks schedule.1

Of the patients in the RP2D efficacy group (n=33), treated once every six weeks, 42.4 percent achieved a 50 percent or greater reduction in their prostate-specific antigen (PSA) levels with a median rPFS of 7.9 months (95 percent confidence interval [CI] 2.9, not estimable [NE]) and 21.2 percent of patients continuing therapy. Treatment with pasritamig showed durable disease control and rPFS that compares favorably to historical data in heavily pretreated patients with mCRPC.1

Metastatic castration-resistant prostate cancer occurs in a significant portion of prostate cancer patients, with many progressing despite initial therapies.2 Overall survival from diagnosis of mCRPC patients ranges from 13.5 to 31.6 months, and lower in patients who have progressed on therapy.3 Treatment options remain limited, underscoring the urgent need for safer and more effective therapies.4

About Pasritamig (JNJ-78278343)
Pasritamig (JNJ-78278343) is an investigational T-cell-engaging bispecific antibody (bsAb) targeting human kallikrein 2 (KLK2) on prostate cancer cells and CD3 on T-cells. This approach is being evaluated in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC), a patient population with limited treatment options.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic castration-resistant prostate cancer (mCRPC) is a challenging and aggressive stage of prostate cancer where the disease progresses despite androgen deprivation therapy.2 Patients often experience metastasis to bones and lymph nodes, leading to poor outcomes and limited treatment options, including chemotherapy and second-line hormone therapies.5 The median overall survival ranges from 13.5 to 31.6 months depending on the site of metastasis, with a typical range of 15–36 months across the broader population.3,6 Survival rates can vary significantly depending on factors such as prior treatment history, disease burden, and response to therapy. The need for more effective treatments is critical, as the disease continues to impact a large number of men globally, with mCRPC being responsible for a substantial number of prostate cancer-related deaths.

On June 1, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy (Press release, Taiho, JUN 1, 2025, View Source [SID1234653566]). Results from the REZILIENT1 trial will be presented in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8503).

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The full publication, titled Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab, can be found here.

Highlights of the REZILIENT1 Phase 1/2 trial in the authors’ conclusions include:

Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab.
The confirmed objective response rate (ORR) was 35.2% overall, and median duration of response (mDOR) and progression-free survival were 8.8 months and 9.4 months, respectively.
In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months.
The safety profile of zipalertinib was manageable and consistent with previously reported data.¹
In exploratory subgroup analyses:
Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months.
Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months.
"Despite recent treatment advances for patients with EGFR ex20ins-mutant NSCLC, there is a lack of oral targeted therapies for patients whose tumors harbor these mutations," said principal investigator Zofia Piotrowska, MD, Assistant Professor, Medicine, Harvard Medical School and a clinical researcher and lung cancer medical oncologist at the Massachusetts General Hospital Cancer Center. "Findings from the Phase 1/2 REZILIENT1 trial support our understanding of zipalertinib as a potential targeted therapy option for patients living with previously treated recurrent or metastatic NSCLC harboring EGFR ex20ins mutations."

Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial (NCT05973773).

About REZILIENT1
REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations
NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,3 with insertions at exon 20 accounting for up to 12% of these mutations.