On June 3, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in solid tumors without lymphodepletion at the 6th Annual Allogeneic Cell Therapies Summit to be held in Boston, MA, from June 10-12, 2024 (Press release, NKGEN Biotech, JUN 3, 2024, View Sourcenkgen-biotech-to-present-updated-phase-1-data-on-snk02-allogeneic-nk-cell-therapy-in-solid-tumors-at-the-6th-annual-allogeneic-cell-therapies-summit-2024/" target="_blank" title="View Sourcenkgen-biotech-to-present-updated-phase-1-data-on-snk02-allogeneic-nk-cell-therapy-in-solid-tumors-at-the-6th-annual-allogeneic-cell-therapies-summit-2024/" rel="nofollow">View Source [SID1234644021]).

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Presentation Details:

Title: Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function

Conference Track: Clinical Track

Date and Time: Wednesday, June 12, 2024, 12:00 pm ET

Dr. Song’s presentation will detail the Company’s novel allogeneic blood-derived NK cell therapy ("SNK02") commercial manufacturing and cryopreservation process, as well provide an update on their initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors. Furthermore, Dr. Song will explore the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function, and potentially enhancing treatment efficacy. The presentation will also include a discussion on an unexpected discovery from the SNK02 Phase 1 trial, hinting at its possible applicability as a treatment for patients beyond cancer.

A copy of the presentation will be available on the Scientific Publications page of the Company’s website at View Source once the presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK02 on advanced solid tumors, which may not be included in this conference presentation, can also be found on the Scientific Publications page.

About SNK02

SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic NK cell immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.

On June 3, 2024 RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, reported the results of the first-in-human, single-arm, open-label, multi-center Phase I/II study evaluating RC88 in patients with MSLN-expressing advanced solid tumors on June 3, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2024) held in Chicago from May 31-June 4, 2024 (Press release, RemeGen, JUN 3, 2024, View Source [SID1234644037]). The first author, Professor Liu Yutao, from the Chinese Academy of Medical Sciences Cancer Hospital, presented RemeGen’s poster session (Poster #422) of this study that focused on efficacy and safety in patients with ovarian cancer, non-squamous non-small cell lung cancer, and cervical cancer.

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RC88 is a novel, first-in-class, antibody-drug conjugate (ADC) developed by RemeGen that targets mesothelin (MSLN) with a monomethyl auristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to MMAE which acts as a microtubule inhibitor. RC88 has a high affinity for MSLN and can specifically bind to MSLN overexpressing tissues. In this study, RC88 has demonstrated a terminating effect on tumor cells with various levels of MSLN expression. RC88 has demonstrated anti-tumor activity and a manageable RC88 monotherapy safety profile in MSLN-positive advanced solid tumors. Preclinical studies showed that RC88 can selectively deliver a potent cytotoxic payload to MSLN-expressing cells through internalization, thus inducing G2/M arrest and apoptosis.

Patients with MSLN-expressing advanced malignant solid tumors that had failed standard therapies were enrolled in this study. For the Phase II study, the primary endpoint was overall response rate (ORR) per RECIST v1.1 criteria-based endpoints, with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety.

As of February 21, 2024, 170 patients with advanced solid tumor were enrolled. The dose escalation phase was completed, and 2.0 mg/kg and 2.5 mg/kg Q3W doses were expanded into Phase II.

In the ovarian cancer (OC) cohort, 54 patients were enrolled, all with 2+ or 3+ MSLN expression. Of these, 40 (74.1%) had an ECOG score of 1; 33 (61.1%) had received prior bevacizumab treatment, and 28 (51.9%) had prior PARP inhibitor (PARPi) exposure. As of March 22, 2024, a total of 31 patients in the 2.0mg/kg group who had received two to four lines of prior therapies were efficacy-evaluable. Among them, the ORR and confirmed ORR (cORR) were 45.2% (14/31, 95%CI 27.3, 64.0) and 41.9% (13/31, 95%CI 24.5, 60.9), respectively. The median DoR was 8.02 months (95%CI 2.83, 8.54).

In the non-squamous non-small cell lung cancer (NSCLC) cohort, 16 EGFR/ALK wild-type (WT) patients were efficacy-evaluable. The ORR and cORR were 31.3% (5/16) and 25% (4/16), respectively. Among the above patients with MSLN high expression (PS2#≥50), the ORR, cORR, median PFS and median DoR were 41.7% (5/12), 33.3% (4/12), 6.87 months and 9.13 months, respectively.

In the cervical cancer (CC) cohort, 18 patients who had progressed on previous systemic therapies were enrolled. The ORR and cORR were 33.3% (6/18) and 27.8% (5/18), respectively. Among the 12 patients that received ≥ 2 lines of therapies, the ORR and cORR were 41.7% (5/12) and 33.3% (4/12), respectively.

"Currently, chemotherapy is the standard of care for OC with an ORR rate of 12%. The promising results of 41.9% ORR from this study underscore the potential of RC88 to significantly improve outcomes for patients with MSLN-expressing advanced solid tumors," said Dr. Fang Jianmin, CEO of RemeGen. "We are committed to advancing our innovative therapies to address these huge unmet medical needs and enhance patient care."

On June 3, 2024 InvoX Pharma Limited ("invoX"), a research-driven global biopharmaceutical company with an advancing pipeline of innovative products, reported updated findings from its ongoing phase 1 study of FS222, an investigational CD137/PD-L1 bispecific antibody, in patients with advanced solid tumours (Press release, InvoX Pharma, JUN 3, 2024, View Source [SID1234644053]). These data demonstrated encouraging anti-tumour activity in multiple tumour types with a manageable safety profile. These preliminary findings were presented today at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago as an oral presentation during the Development Therapeutics – Immunology Session.

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FS222 is a novel tetravalent bispecific antibody, using invoX’s proprietary Fcab platform technology, that drives PD-L1 dependent CD137 agonism. The data presented today are from 100 subjects in the ongoing first-in-human (FIH) dose-escalation phase 1 clinical trial of FS222 (NCT04740424) in patients with advanced solid tumours. The study is designed to evaluate safety and identify the maximum tolerated dose, with secondary objectives related to anti-tumour activity, pharmacokinetics, and pharmacodynamics.

As a monotherapy dosed once every 4 weeks, FS222 increased T cell proliferation and intratumoural CD8+ T cell infiltration across a wide range of doses. The rate of treatment-related adverse events (TRAEs) was generally dose dependent. Overall, TRAEs were consistent with the intended dual mechanism of action of CD137 agonism and PD-L1-blockade and were generally manageable and reversible. Grade ≥ 3 TRAEs occurred in 36/100 subjects, with the most common including increases in aspartate aminotransferase and alanine aminotransferase, thrombocytopenia, neutropenia and febrile neutropenia.

In the study, FS222 demonstrated encouraging anti-tumour activity in multiple tumour types. Responses (as defined by RECIST1.1 criteria) were observed in cutaneous melanoma (n=9), ovarian cancer (n=2), non-small cell lung cancer (NSCLC) (n=2), and one each for mucosal melanoma, triple negative breast cancer (TNBC), mesothelioma and MSS colorectal cancer. The rate of disease control (defined as the rate of complete responses, partial responses and stable disease combined) was 45.0% for all patients in the study.

In 19 patients with metastatic/advanced cutaneous melanoma previously treated with a PD-1 antibody the overall response rate (defined as the rate of complete responses and partial responses combined) was 47.4% and the disease control rate was 68.4%.

Elena Garralda, MD, MSc, Director of Early Drug Development at Vall d’Hebron University Hospital, said: "While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response rates and duration of response, especially in treatment-resistant cancer. The opportunity to target multiple complementary immune mechanisms with a single agent is very exciting and has significant potential to address an unmet need for patients. These results for FS222 are really encouraging and should be studied further, as they show a promising anti-tumour effect with a manageable safety profile."

Ben Toogood, Chief Executive Officer at invoX, said: "We are encouraged by these results and are impressed by the preliminary anti-tumour activity observed with FS222, especially in melanoma patients previously treated with a PD-1 antibody. There is an urgent need for innovative immuno-oncology treatments for patients with treatment-resistant cancers. We see significant potential for FS222 in this area and will continue to investigate FS222 further, with the aim of providing benefit to patients in the future."

Ben added: "These data also provide important validation of our antibody platform. We are excited about the potential to utilise our proprietary CD137-agonist domain from our Fcab platform in additional bispecific antibodies targeting multiple tumour types and patient populations."

Enrollment in this phase 1 study of FS222 is ongoing and the study is exploring additional FS222 dose optimization.

On June 2, 2024 GSK plc (LSE/NYSE: GSK) reported positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma (Press release, GlaxoSmithKline, JUN 2, 2024, View Source [SID1234643926]). These late-breaking data, being presented today at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (31 May – 4 June) in Chicago, IL, were featured in the official ASCO (Free ASCO Whitepaper) press programme and simultaneously published in the New England Journal of Medicine.

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On the primary endpoint of progression-free survival (PFS), a statistically significant and clinically meaningful improvement (hazard ratio [HR]: 0.52 [95% confidence interval (CI): 0.37-0.73], p-value<0.001) was observed with the belantamab mafodotin combination (n=155) compared to the bortezomib combination (n=147). At a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the belantamab mafodotin combination compared to 12.7 months (95% CI: 9.1-18.5) in the bortezomib combination. At the end of one year, 71% (95% CI: 63-78) of patients in the belantamab mafodotin combination group compared to 51% (95% CI: 42-60) in the bortezomib combination group were alive and had not progressed. A benefit for belantamab mafodotin plus PomDex was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "With the robust results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for Blenrep combinations to redefine the treatment of multiple myeloma at or after first relapse. This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators."

A positive overall survival (OS) trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned. At the end of one year, 83% (95% CI: 76-88) of patients were alive in the belantamab mafodotin combination group versus 76% (95% CI: 68-82) in the bortezomib combination group. The safety and tolerability profile of the belantamab mafodotin combination was broadly consistent with the known profile of the individual agents.

Suzanne Trudel, MD, Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada, said: "The profound progression-free survival benefit seen in DREAMM-8 highlights the potential for belantamab mafodotin, when used with pomalidomide and dexamethasone, to improve outcomes for patients with relapsed/refractory multiple myeloma. This combination may have potential to redefine treatment of multiple myeloma at or after first relapse, a setting where patients may benefit from novel therapies.

Similar to the results seen in the DREAMM-7 phase III head-to-head trial, in DREAMM-8 the belantamab mafodotin combination also resulted in clinically meaningful improvements consistently across secondary efficacy endpoints, showing that the belantamab mafodotin combination resulted in deeper and more durable responses compared to the bortezomib combination. Key improvements included rate of complete response (CR) or better (more than twofold improvement); minimal residual disease (MRD) negativity rate (nearly fivefold improvement); and duration of response (median not yet reached with the belantamab mafodotin combination versus 17.5 months with the bortezomib combination).

Key and other secondary endpoint summaries are listed below.

Key and Other Secondary Endpoints
Endpoint belantamab mafodotin + pomalidomide and dexamethasone (BPd)
(n= 155) pomalidomide + bortezomib and dexamethasone (PVd)
(n=147)
ORR (overall response rate), % (95% CI)

77% (70.0-83.7)

72% (64.1-79.2)

sCR (stringent complete
response), %

9%

3%

CR (complete response),
%

31%

14%

VGPR (very good partial
response), %

24%

22%

PR (partial response), %

14%

34%

CR or better rate
(sCR+CR), % (95% CI)

40% (32.2-48.2)

16% (10.7-23.3)

VGPR or better rate
(sCR+CR+VGPR), %
(95% CI)

64% (55.8-71.4)

38% (30.2-46.5)

MRD negativity rate* %
(95% CI)

23.9% (17.4-31.4)

4.8% (1.9-9.6)

Duration of response
(months), median (95% CI)

NR (24.9-NR)

17.5 months (12.1-26.4)

Overall Survival**
HR (95% CI)  0.77 (0.53-1.14)
* Measured in patients with a sCR or CR.
** Follow-up for OS is ongoing.
NR: Not reached.

Grade 3 or higher non-ocular adverse events (AEs) of clinical interest in the belantamab mafodotin combination versus bortezomib combination arms, respectively, included neutropenia (57% versus 39%; 42 patients/100 person-years in both arms); thrombocytopenia (38% versus 29%; 28 versus 31 patients/100 person-years); and pneumonia (17% versus 8%; 13 versus 8 patients/100 person-years).

Eye-related side effects, a known risk of treatment with belantamab mafodotin, were generally reversible, manageable with dose modifications, and led to low (9%) treatment discontinuation rates. Grade 3 or higher ocular adverse events occurred in 43% of patients receiving the belantamab mafodotin combination (Grade 3: 42%; Grade 4: 1%). Most commonly reported grade 3 or higher ocular symptoms included blurred vision (Grade 3: 17%; Grade 4: 0), dry eye (Grade 3: 8%: Grade 4: 0), and foreign body sensation in the eyes (Grade 3: 6%; Grade 4: 0). Fifty-one patients (34%) with a best corrected visual acuity (BCVA) of 20/25 or better in at least one eye at baseline had a worsening in both eyes to 20/50 or worse. At the time of this analysis, the first occurrence of such events had improved in 92% of these patients, and resolved in 85%, with a median time to resolution of 57 days (range: 14-451 days).

Global health status quality of life (QOL), as measured by the EORTC-QLQ-C30 remained stable in both treatment arms over time, suggesting that treatment did not lead to any decline in overall health related QOL.

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development programme continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. DREAMM-8 is the second phase III head-to-head belantamab mafodotin combination trial in second line and later treatment for multiple myeloma to report positive results. Positive findings from DREAMM-7, a phase III head-to-head trial evaluating belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex in the same treatment setting, were presented1 at the ASCO (Free ASCO Whitepaper) Plenary Series on 6 February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with PomDex compared to a combination of bortezomib and PomDex in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 75% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

A total of 302 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

The primary endpoint is PFS as per an independent review committee. Key secondary endpoints include OS, minimal residual disease negativity as assessed by next-generation sequencing, and duration of response. Other secondary endpoints include ORR, patient-reported quality of life outcomes, adverse events, eye exam findings, and laboratory investigations.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.2,3 There are approximately 176,000 new cases of multiple myeloma diagnosed globally each year.4 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.5

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Refer to the Blenrep UK Summary of Product Characteristics6 for a full list of adverse events and the complete important safety information in the United Kingdom.

On June 2, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that results from the pivotal Phase 2 TRUST-I study conducted in China evaluating taletrectinib, next-generation ROS1 tyrosine kinase inhibitor (TKI), were published today in the Journal of Clinical Oncology (JCO) and will be highlighted in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2024, View Source [SID1234643943]).

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Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. Results showed taletrectinib shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 91% of patients who were ROS1 TKI-naïve and 52% of patients who had previously been treated with crizotinib (ROS1 TKI-pretreated). Taletrectinib continued to show robust activity in patients with disease that spread to the brain, as well as in patients with acquired resistance mutations, including G2032R.

After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively. Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).

Based on positive results from the pivotal Phase 2 TRUST-I study, two new drug applications (NDA) of taletrectinib have been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, and granted priority review designations, for first-line and second-line treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

"Current treatments for advanced ROS1-positive NSCLC have significant limitations, and people living with this disease remain in need of new options that are both well tolerated and offer durable responses," said Caicun Zhou, M.D., Ph.D., Principal Investigator of the TRUST-I study and Professor and Director of the Department of Oncology at Shanghai East Hospital, Tongji University. "These TRUST-I results reinforce taletrectinib’s strong efficacy and favorable safety profile, with longer follow-up, taletrectinib continues to show high and durable overall responses, robust intracranial and G2032R activity, with a low incidence of neurologic AEs. We look forward to taletrectinib benefits ROS1-positive NSCLC patients in the near future."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, " The updated data of the TRUST-I study shows remarkably durable response and meaningful clinical benefits of taletrectinib for ROS1-positive NSCLC patients. We will continue close communications with our partner and regulatory authorities in China, hoping to bring this new generation of targeted therapy to patients with ROS1-positive NSCLC in China."

About ROS1-positive NSCLC

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 1-3% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors (TKIs).

In 2021, Innovent and AnHeart Therapeutics, a Nuvation Bio (NYSE: NUVB) Company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About Phase 2 TRUST-I Study Results

TRUST-I (NCT04395677) is a pivotal Phase 2, multicenter, single-arm, open-label study evaluating taletrectinib as a monotherapy in 173 patients with advanced ROS1-positive NSCLC in China who either had not previously been treated with a ROS1 TKI (TKI-naïve) or had previously been treated with crizotinib (TKI-pretreated). Almost all patients received 600 mg of taletrectinib orally once-a-day in 21-day treatment cycles. 21% of TKI-naïve patients and 34% of TKI-pretreated patients had received prior chemotherapy, respectively. The primary endpoint of this registrational study was cORR as assessed by IRC, and key secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.

As of November 29, 2023, results from TRUST-I as assessed by an IRC showed:

In TKI-naïve patients (n=106):

90.6% of patients’ tumors shrank in response to taletrectinib treatment (cORR).
Taletrectinib shrank brain tumors in 87.5% of people who had measurable central nervous system tumors (n=8; intracranial cORR).
After median follow-up of 23.5 months, median duration of response and median progression-free survival were not reached.
At two years, 78.6% of patients who responded to taletrectinib treatment were still responding and 70.5% of patients were still progression-free.
In TKI-pretreated patients (n=66):

51.5% of patients’ tumors shrank in response to taletrectinib treatment (cORR).
Taletrectinib shrank brain tumors in 73.3% of people who had measurable central nervous system tumors (n=15; intracranial cORR).
Taletrectinib shrank tumors in 66.7% of patients with G2032R mutations (n=12).
After median follow-up of 9.7 months, median duration of response was 10.6 months and median progression-free survival was 7.6 months.
At nine months, 69.8% of patients who responded to taletrectinib treatment were still responding and 47.4% were still progression-free.
Taletrectinib’s safety profile was consistent with previous reports. The most frequent TEAEs were increased liver enzymes (increased aspartate aminotransferase: 76%; increased alanine aminotransferase: 68%); diarrhea (70%); vomiting (53%), and anemia (49%), most of which were grade 1 or 2. Incidence of neurologic TEAEs were low; the most common was dizziness (23%), most of which was grade 1. Discontinuations (5%) and dose reductions (19%) due to TEAEs were low.

The JCO publication, "Efficacy and Safety of Taletrectinib in Chinese Patients with ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study," is available at View Source

The corresponding oral presentation of the same name (Abstract #8520) will be delivered by Wei Li, M.D., a TRUST-I investigator and Professor at the Department of Medical Oncology at Shanghai East Hospital, Tongji University, at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in the "Lung Cancer – Non-Small Cell Metastatic" session occurring today, Saturday, June 1, 2024, at 4:30-6:00 p.m. CT/5:30-7:00 p.m. ET.