Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting
Nuvation Bio has published data from its Phase 2 TRUST-I study of taletrectinib, a ROS1 inhibitor, in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting.
This study involved 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in China. Results showed that tumors shrank in 91% of ROS1 TKI-naïve and 52% of ROS1 TKI-pretreated patients.
Long-term follow-up indicated 71% of TKI-naïve patients remained progression-free at two years. The study highlighted taletrectinib's effectiveness in patients with brain metastases and resistance mutations.
Safety profile was consistent with previous reports, showing low incidence of neurologic treatment-emergent adverse events.
- Tumors shrank in 91% of TKI-naïve and 52% of TKI-pretreated patients.
- Long-term follow-up showed 71% of TKI-naïve patients were progression-free at two years.
- Taletrectinib was effective in patients with brain metastases and resistance mutations.
- Safety profile consistent with previous reports, low incidence of neurologic adverse events.
- 51.5% of TKI-pretreated patients experienced tumor shrinkage, lower than TKI-naïve.
- Median progression-free survival for TKI-pretreated patients was only 7.6 months.
- High incidence of non-neurologic adverse events, including increased liver enzymes and diarrhea.
- 5% discontinuation rate and 19% dose reduction due to adverse events.
Insights
From a financial perspective, this news is highly relevant for investors. Nuvation Bio has reported promising results from its Phase 2 studies, indicating a potential breakthrough in the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Notably, the data shows a
The company's plan to share results from the global TRUST-II study by the end of 2024, combined with their aim to become a commercial-stage organization by the end of 2025, aligns with a strategic roadmap that could substantially elevate their market position. Investors should monitor these developments closely as successful commercialization could translate into significant revenue growth.
Additionally, the safety profile of taletrectinib being in line with previous reports and the low incidence of discontinuations (
For someone in the medical field, particularly in oncology, the efficacy data of taletrectinib is quite impressive. Taletrectinib has shown to shrink tumors in
Moreover, the drug also demonstrated efficacy in patients with brain metastases and those with acquired resistance mutations, such as G2032R. This broad spectrum of activity is important because it addresses a major clinical challenge: resistance to existing TKIs. The long-term durability of the responses, with a median progression-free survival not reached in TKI-naïve patients after a median follow-up of 23.5 months, is particularly noteworthy as it suggests prolonged benefits without disease progression.
The safety profile, with the most common TEAEs being manageable and mostly grade 1 or 2, makes taletrectinib an attractive option for patients, potentially improving their quality of life while managing this chronic condition.
From a market research standpoint, these results position Nuvation Bio favorably within the competitive landscape of oncology treatments. The high cORR and durable response rates in the TRUST-I study could differentiate taletrectinib from existing treatments, potentially positioning it as a best-in-class option for ROS1-positive NSCLC. It could capture substantial market share if it continues to show similar results in the TRUST-II study and gains regulatory approval.
The timing of the publication in the Journal of Clinical Oncology and the presentation at the ASCO Annual Meeting is strategic, enhancing visibility among key stakeholders, including clinicians and potential investors. This visibility can drive market perception positively, potentially leading to partnerships, collaborations, or even acquisition interest from larger pharmaceutical companies looking to bolster their oncology portfolios.
Moreover, the planned timeline to achieve commercial-stage status by the end of 2025 aligns with a growing demand for innovative cancer treatments, which could see a surge in market interest and stock performance as key milestones are reached. Investors should watch for updates on both the TRUST-II study and any regulatory submissions.
Tumors shrank in
Responses were durable with long-term follow-up;
TRUST-I is one of two registrational Phase 2 studies evaluating taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC
Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. Results showed tumors shrank (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in
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).
“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 signal and favorable safety profile, underscoring its potential to become a new treatment option for patients.”
“TRUST-I is one of the largest prospective trials conducted to date in ROS1-positive NSCLC. We now have data with long-term follow-up and are very pleased that results remain highly consistent with previously reported taletrectinib data, demonstrating its best-in-class potential,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We look forward to further advancing taletrectinib and plan to share results from the global, pivotal TRUST-II study by the end of 2024, as we aim to become a commercial-stage organization by the end of 2025.”
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
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 following treatment with taletrectinib (cORR). -
Brain tumors shrank in
87.5% of taletrectinib-treated patients 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 following treatment with taletrectinib were still responding, and70.5% of patients were still progression-free.
In TKI-pretreated patients (n=66):
-
51.5% of patients’ tumors shrank following treatment with taletrectinib (cORR). -
Brain tumors shrank in
73.3% of taletrectinib-treated patients who had measurable central nervous system tumors (n=15; intracranial cORR). -
Tumors shrank in
66.7% of taletrectinib-treated 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 following treatment with taletrectinib were still responding, and47.4% were still progression-free.
Taletrectinib’s safety profile was consistent with previous reports. The most frequent TEAEs were increased liver enzymes (increased aspartate aminotransferase:
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 https://ascopubs.org/doi/10.1200/JCO.24.00731.
The corresponding oral presentation, “Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1+ Non-Small Cell Lung Cancer: The Phase 2 TRUST-I Study,” (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 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, and will be made available on Nuvation Bio’s website at www.nuvationbio.com/publications.
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
In 2021, AnHeart Therapeutics Ltd., a Nuvation Bio company, entered into an exclusive license agreement with Innovent Biologics, Inc. for the co-development and commercialization of taletrectinib in
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
About Nuvation Bio
Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-868 (BET), and NUV-1511 (DDC). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, the potential for taletrectinib to become a new therapeutic option for ROS1-positive NSCLC, taletrectinib’s best-in-class therapeutic potential, the expected timing of establishing a commercial organization, and the expected timing for sharing results from the TRUST-II study. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; competitive developments; and establishing commercial capabilities. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 14, 2024, under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
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