On June 2, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, reported new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM) (Press release, In8bio, JUN 2, 2025, View Source [SID1234653611]). The data were presented in an oral session on May 30th at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Half of the patients who received multiple doses remained progression free for greater than a year and a half, demonstrating functional recoveries, with several patients also having the ability to return to work. No new relapses have been reported since the last clinical update in October 2024" stated Burt Nabors, M.D., Division Director, Neuro-Oncology at the Heersink School of Medicine at the University of Alabama at Birmingham and Principal Investigator of the study. "These early data highlight the potential of repeated intracranial dosing of IN8bio’s gamma-delta T cells to extend mPFS in GBM, including in patients with chemotherapy-resistant tumors."

The Phase 1 results of INB-200 demonstrate that repeated dosing of IN8bio’s proprietary Drug Resistant Immunotherapy (DRI) – which utilizes genetically modified gamma-delta T cells delivered directly into the brain – in combination with SOC maintenance chemotherapy (temozolomide), led to an mPFS of 16.1 months. This represents an improvement of more than double (+9.2 months or +132.6%) the historical mPFS of 6.9 months under the SOC Stupp protocol. These mPFS results have already surpassed the historical mOS of 14.6 months associated with the SOC Stupp protocol alone. By comparison, a 2 to 3 month improvement in mPFS has historically been considered as clinically significant and the bar for approval by the Food and Drug Administration (FDA).

Importantly, no dose-limiting toxicities (DLTs), CRS, or ICANS have been observed among patients treated with INB-200 (n=13). The majority of adverse events were Grade 1-2 and consistent with those typically associated with radiation and temozolomide. No treatment-related deaths have occurred.

Highlights from the Clinical Data as of May 31, 2025:

INB-200

Four patients (40%) who received repeated doses of INB-200 remain alive and progression free for a median of over two years, with three returning to work
No additional relapses were observed since the last data update on October 18, 2024
Among patients who received multiple doses of INB-200, mPFS reached 16.1 months, compared to 6.9 months with SOC and 8.3 months for patients who received only a single dose of INB-200
Repeat dosing demonstrated no additional safety risks, with most side effects being mild and attributable to the SOC therapy
50% of patients receiving repeated doses remained progression-free >18 months versus 0% of patients who received a single dose

INB-400

Data from our Phase 2 clinical trial of INB-400 in patients with newly diagnosed GBM, including three additional clinical sites, also show encouraging preliminary results: current mPFS is at 10.8 months. Additional updates expected late 2025

"Our goal is to achieve deeper responses and eliminate more cancer cells to ultimately extend the time patients can remain progression free and alive," stated William Ho, CEO and cofounder of IN8bio. "The data presented at ASCO (Free ASCO Whitepaper) by Dr. Nabors speaks to the potential of IN8bio’s gamma-delta T cells to provide a game-changing immunotherapy for this dire and life-threatening cancer. We believe that INB-200 represents a novel direction in therapy for the treatment of solid tumor cancers like GBM. The complete data from our Phase 1 trial and supporting data from our Phase 2 trial represent the first time a gamma-delta T cell therapy has shown the potential to extend mPFS beyond historical benchmarks."

IN8bio’s approach delivers gamma-delta T cells directly to the tumor cavity after surgery, applying sustained immune pressure to eliminate residual cancer cells. The Company’s DRI technology is designed to treat newly diagnosed GBM by harnessing the natural tumor-targeting power of gamma-delta T cells and the sensitizing effects of chemotherapy. This approach aims to eliminate the chemo-resistant cancer and stem cells that often survive SOC treatment and can lead to relapse.

Conference Call Details

IN8bio will host a conference call and webcast featuring Dr. Burt Nabors, the Principal Investigator, today, Monday, June 2, 2025 at 8:30 am EDT to review the updated clinical data from the ASCO (Free ASCO Whitepaper) presentation. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Company’s website. To participate in the live call, please register using this link. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.

(1) Historical reported mPFS and mOS from Stupp Protocol (surgery, radiotherapy plus maintenance temozolomide); doi: 10.1056/NEJMoa043330

On June 2, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the 2025 Jefferies Global Healthcare Conference (Press release, Immunocore, JUN 2, 2025, View Source [SID1234653610]).

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2025 Jefferies Global Healthcare Conference
Fireside Chat: Thursday, June 5, 2025, at 11:05 a.m. EDT

The presentation will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

On June 2, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield platform, anchored by ANKTIVA (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation, or immunotherapy (Press release, ImmunityBio, JUN 2, 2025, View Source [SID1234653609]).

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To date no treatment exists for lymphopenia, a depletion of critical lymphocytes responsible for immunogenic cell death, specifically natural killer (NK) cells, killer CD8+ T cells and CD4+ with memory T cells. Treatment induced lymphopenia is a debilitating consequence of chemotherapy, radiation, and certain immunotherapies and steroids. This treatment-acquired immunodeficiency not only increases susceptibility to infections but also deprives the body’s immune system to fight residual or recurrent cancer, accelerating metastasis and disease progression, and contributing to early mortality. Countless publications over the last two decades has reported lymphopenia as a highly predictive biomarker of poor prognosis across all tumor types.1-6 Despite its significant clinical impact, the pharmaceutical industry has largely overlooked lymphopenia as a disease in its own right, and no approved therapies have existed to directly address it, until the approval of ANKTIVA in the treatment of BCG-unresponsive bladder cancer with the mechanism of action of an IL-15 superagonist proliferating key lymphocytes.7

While oncologists and patients have long had therapies such as EPOGEN and NEUPOGEN to manage chemotherapy- and radiation-induced anemia and neutropenia, no comparable option has been available for lymphopenia. ANKTIVA, an interleukin-15 (IL-15) agonist, is the first approved therapy with a defined mechanism of action to restore lymphocyte levels. It activates and proliferates NK and T cells without inducing immunosuppressive regulatory T cells (Tregs), offering the first solution for reversing this critical immune deficit of lymphocytes in cancer patients.7

"Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA. The survival benefit we observed at ASCO (Free ASCO Whitepaper) 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease."

At the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, ImmunityBio presented landmark results showing that reversing lymphopenia with ANKTIVA and CAR-NK therapy significantly prolonged median overall survival in third- to sixth-line metastatic pancreatic cancer patients. This benefit was further enhanced when treatment began at lower tumor burdens, as indicated by CA19-9 levels. Highlighting the importance of lymphopenia reversal, Oncologist published a peer-reviewed paper titled "Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate," demonstrating that the patient with 2nd line metastatic pancreatic cancer treated with the full Cancer BioShield platform—including ANKTIVA, CAR-NK cells (PD-L1 t-haNK), and antigen-targeting adenoviruses—has remained in remission for over six years and maintains a high quality of life at the date of this release.

"We are entering a new era in oncology where the goal is not only to target the tumor but to protect and empower the immune system itself," continued Dr. Soon-Shiong. "Through this Expanded Access Program, we can now offer hope to patients with solid tumors who have exhausted standard options. Our mission is to transform cancer care by reversing the immune collapse that often leads to progression and mortality by enabling the body to serve as a factory for the regeneration and reconstitution of the lymphocytes key to immunogenic cell death of the tumor. By mitigating treatment induced lymphopenia from our standards of care, ANKTIVA can serve as a Cancer Bioshield."

In February 2025, ImmunityBio announced it had received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for ANKTIVA and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in relapsed locally advanced or metastatic pancreatic cancer. The RMAT designation is intended to expedite the development of therapies targeting serious or life-threatening conditions with unmet medical need.

Full results of our 2025 ASCO (Free ASCO Whitepaper) Annual Meeting can be found below:

Association of lymphopenia rescue and CA19-9 levels with overall survival following IL-15 superagonist N-803 and PD-L1 t-haNK chemo-immunotherapy for 3rd line or greater metastatic pancreatic cancer.
Abstract Text: View Source
Poster PDF: View Source

QUILT 3.076 phase 1 study of memory-like cytokine-enriched natural killer (M-CENK) cells plus N-803 in locally advanced or metastatic solid tumors.
Abstract Text: View Source
Poster PDF: View Source

About the Cancer BioShield Platform

The Cancer BioShield platform is a first-in-class immunotherapy strategy designed to restore immune competence by reversing lymphopenia—the loss of functional immune cells caused by cancer itself and by conventional treatments such as chemotherapy, radiation and immunotherapy. At its core is ANKTIVA (nogapendekin alfa inbakicept-pmln), an IL-15 agonist approved for BCG-unresponsive non–muscle-invasive bladder cancer CIS with or without papillary disease, activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells, restoring lymphocyte levels critical for immunosurveillance, immunogenic cell death, and long-term tumor control.

The platform employs a multi-modal approach:

In-vivo stimulation: Subcutaneous administration of ANKTIVA expands NK and T cells, boosting anti-tumor immunity.
Ex-vivo targeted cytotoxicity: Off-the-shelf PD-L1 t-haNK CAR-NK cells are engineered to target and eliminate PD-L1–expressing tumor cells and immunosuppressive neutrophils (myeloid-derived suppressor cells), enhancing anti-tumor specificity and reducing immune evasion.
Memory Cytokine-Enriched Natural Killer (M-ceNK) cell therapy: M-ceNK cells are developed via cytokine activation and expansion of autologous and allogeneic NK cells collected through apheresis, potentially providing long-term immune memory and sustained cytotoxic capacity.
Together, these components offer a comprehensive, novel, immune-restoring therapeutic platform aimed at not only expanding effector immune cells, but also overcoming tumor-mediated immune suppression to support long-term disease control.

The platform’s effectiveness can be tracked through universally utilized simple complete blood count (CBC): increases in absolute lymphocyte count (ALC) reflect ANKTIVA’s lymphocyte-stimulating activity, while reductions in the neutrophil-to-lymphocyte ratio (NLR) demonstrate PD-L1 t-haNK’s immunosuppressive neutrophil targeting. Low ALC and high NLR levels6 are laboratory measurements that have been extensively reported as predictive biomarkers of poor prognosis with early mortality across all tumor types.1-6 The data presented by ImmunityBio for the first time demonstrates that improving ALC and NLR correlates with significant enhanced overall survival and clinical benefit.

With potential applications extending beyond oncology—including infectious disease, sepsis, and immune senescence—the Cancer BioShield Platform represents a potentially transformative shift in treating not just the tumor, but the underlying immune collapse that allows disease to progress.

About Lymphopenia and Absolute Lymphocyte Count (ALC)

Lymphopenia—the loss of key immune cells such as NK, CD4+, and CD8+ T cells—is a common side effect of chemotherapy1, radiation2,3, and some immunotherapies4. Unlike anemia and neutropenia, which have FDA-approved treatments like EPOGEN and NEUPOGEN, no therapy previously existed to treat this immune cell depletion. Lymphopenia weakens the immune system, increases infection risk, and is linked to early death across many cancer types.1-6 Low Absolute Lymphocyte Count (ALC) is a recognized poor prognostic marker. ANKTIVA is the first approved therapy to restore lymphocyte levels by activating and expanding NK and T cells—without increasing immunosuppressive T regulatory cells.

On June 2, 2025 Ichnos Glenmark Innovation (IGI), a global, fully integrated clinical-stage biotechnology company focused on developing multispecificsTM in oncology, reported promising full dose-escalation results from its Phase 1 TRIgnite-1 study of ISB 2001, an investigational first-in-class BCMA × CD38 × CD3-targeting trispecific antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) (Press release, Ichnos Sciences, JUN 2, 2025, View Source;utm_medium=rss&utm_campaign=igi-asco-isb2001-high-orr-favorable-safety-data [SID1234653608]). These data, presented as a rapid oral presentation (Abstract #7514) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, demonstrated a sustained overall response rate (ORR) of 79% and a high complete/stringent complete response (CR/sCR) rate of 30% across seven active dose levels (≥ 50 µg/kg) in a heavily pretreated patient population, with a favorable safety profile. The ORR was 74% in all treated patients, including two patients treated at lower dose levels.

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ISB 2001 was designed to simultaneously target multiple myeloma by binding to the tumor-associated antigens BCMA and CD38, even when expressed at low levels, while engaging T cells to trigger an immune response. This novel trispecific design enhances tumor-specific cytotoxicity and aims to overcome resistance mechanisms seen with first-generation bispecific antibodies and CAR T-cell therapies, while minimizing off-tumor toxicity.

Professor Hang Quach, M.D., Professor of Haematology at the University of Melbourne and Director of Haematology at St. Vincent’s Hospital Melbourne, said "Responses to ISB 2001 highlight the remarkable anti-myeloma activity of this first-in-class anti-BCMA × CD38 × CD3 trispecific antibody-T cell engager in heavily pretreated RRMM patients, including those who have exhausted prior T cell-redirecting, BCMA-targeted, or anti-CD38 therapies – an especially challenging, quad-exposed patient population. With its unprecedented potency and tolerability, ISB 2001 has the potential to redefine the treatment landscape for RRMM, offering new hope for patients with limited therapeutic options."

A total of 35 patients with at least one month of follow-up had received a median of six prior lines of therapy (range: 3–11) at study entry, underscoring a heavily pretreated population. ISB 2001 demonstrated high response rates at active dose levels, with 33 patients treated at ≥ 50 µg/kg (dose levels 3–9). Responses were durable and deepened over time, irrespective of prior lines of therapy or refractoriness status, reinforcing the strength of earlier findings reported at ASH (Free ASH Whitepaper) 2024 Annual Meeting in 18 patients treated with ISB 2001 at doses ≥ 50 µg/kg:

The ORR was 79% (26/33), including a CR/sCR rate of 30% (10/33), with a median follow-up of 6.3 months (range: 1–16).
Of the 10 patients achieving CR/sCR, eight were evaluable for minimal residual disease (MRD), and six achieved MRD negativity, indicating no detection of myeloma cells by molecular or flow cytometry assays with 10-5 sensitivity, and reinforcing the depth of response.
Among 25 patients refractory to anti-CD38 therapies, the ORR was 72%, with a CR/sCR rate of 24%.
In 19 patients without prior T-cell directed therapy (TCDT), including bispecific antibodies and/or CAR T-cell therapy, the ORR was 84%, with CR/sCR rate of 32%.
Among 14 patients previously treated with TCDT, the ORR remained strong at 71% with a CR/sCR rate of 28%.
In 15 patients who had received prior BCMA-targeted therapies, the ORR was 73%, with a CR/sCR rate of 27%.
The median half-life of ISB 2001 was approximately 17 days, supporting the potential for less-frequent dosing.
ISB 2001 demonstrated a favorable safety profile throughout the dose-escalation phase, with no dose-limiting toxicities (DLTs) reported. Cytokine release syndrome (CRS) occurred in 24 patients (69%), primarily Grade 1, with only four patients experiencing Grade 2 events. CRS was mostly limited to the first administration of ISB 2001, and no severe or life-threatening cases were observed. Drug-related severe infections were infrequent (4 patients, 11%), with no Grade 4 or higher infection. One patient experienced Grade 1 ICANS; no other drug-related neurologic adverse events were reported.

The dose-expansion portion of the Phase 1 study is ongoing to establish the recommended Phase 2 dose (RP2D) and the best dosing schedule to enable the first registrational study with ISB 2001.

"The high response rates and low safety concerns demonstrated in the dose-escalation portion of the TRIgnite-1 study, conducted in a heavily pretreated population across multiple types of therapies, reinforce the promise of ISB 2001 as a potential new treatment for patients," said Lida Pacaud, M.D., Chief Medical Officer at IGI. "As we advance to the second part of the TRIgnite-1 study, our focus is now on defining the recommended dosing schedule and evaluating ISB 2001 in a larger population of heavily pretreated RRMM patients, where we hope to observe similarly impressive treatment responses and tolerability."

About TRIgnite-1

TRIgnite-1 (NCT05862012) is an ongoing Phase 1, first-in-human, open-label, multicenter study evaluating the safety and anti-myeloma activity of ISB 2001 in patients with RRMM. The dose-escalation study enrolled patients with RRMM who were treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies and are refractory to, or intolerant of, established therapies known to provide clinical benefit in multiple myeloma. Patients with prior CAR-T cell therapies, bispecifics and/or prior BCMA targeted agents were eligible.

The TRIgnite-1 study has two parts: dose escalation and dose expansion. The dataset presented comes from patients treated in the entire dose-escalation portion who have at least 1-month follow-up at six sites in the United States and Australia. The dose-expansion study is randomized, compliant with Project Optimus at the U.S. Food and Drug Administration (FDA), and is underway in the U.S. and Australia, with European enrollment beginning soon.

About ISB 2001 and Relapsed/Refractory Multiple Myeloma

ISB 2001 is a first-in-class trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells. Developed using IGI’s proprietary BEAT protein platform, ISB 2001 was engineered with two distinct binders against myeloma-associated antigens to enhance avidity, even at low target expression levels, while aiming to improve safety over first-generation bispecific antibodies.

The U.S. Food and Drug Administration (FDA) granted ISB 2001 Fast Track Designation in May 2025 and Orphan Drug Designation in July 2023.

Nearly all patients with RRMM ultimately experience disease progression. With no cure currently available and limited treatment options once approved therapies are exhausted, there remains a significant unmet need. IGI is developing ISB 2001 to address this gap, specifically for patients who have previously received T-cell–directed therapies, including CAR T-cell treatments and bispecific antibodies.

On June 2, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported primary results from the interim analysis of the SACHI Phase III study (Press release, Hutchison China MediTech, JUN 2, 2025, View Source [SID1234653607]). These results were presented in a late-breaking oral presentation on Sunday, June 1, 2025, during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, USA.

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SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on first-line EGFR inhibitor therapy (clinicaltrials.gov identifier NCT05015608).

Title:

Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and MET-amplification advanced NSCLC after disease progression on EGFR tyrosine kinase inhibitor: Results from a randomized Phase III SACHI study

Lead Author:

Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Session:

Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic

Abstract Number:

LBA8505

Date & Time:

Sunday, June 1, 2025, 8:00 AM Central Daylight Time

Location:

Arie Crown Theater

Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, "The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease."

HUTCHMED will host a webcast to discuss the data presented at the ASCO (Free ASCO Whitepaper) Annual Meeting at 8:30 -9:00 am HKT on Tuesday, June 3, 2025 (8:30 – 9:00 pm EDT on June 2, 2025). The event will be held in English and can be accessed via www.hutch-med.com/event. A replay will also be available on the website shortly after the event.

As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ("PFS") assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ["HR"] 0.34; 95% confidence interval ["CI"] 0.23-0.49; p < 0.0001). The independent review committee ("IRC") assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001).

The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis.

Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ("TKI")–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001).

The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile.

In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA).

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.