On September 14, 2024 Incyte (Nasdaq:INCY) reported new early clinical data for INCB123667, a highly selective, potential first-in-class CDK2 inhibitor, in patients with advanced solid tumors (Press release, Incyte, SEP 14, 2024, View Source [SID1234646605]). The trial results, presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) with new, updated data shared during the Company’s investor event, highlight the potential of INCB123667 as a differentiated treatment option for cancers with increased Cyclin E1 activity, amplification and/or overexpression in cells predictive of CDK2 dependency.

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In the trial, patients with advanced or metastatic solid tumors (n=205) – including ovarian cancer, endometrial cancer, gastrointestinal cancer, HR+/HER2- breast cancer and triple negative breast cancer, among others – received varying doses of INCB123667 ranging from 50mg to 150mg using once-daily (QD) and twice-daily (BID) dosing schedules.

New data from the Phase 1b dose expansion portion of the trial (data cut-off August 26, 2024) presented today during Incyte’s investor event, demonstrate single-agent antitumor activity, and decreases in circulating tumor DNA (ctDNA) across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The trial is ongoing, and the data will continue to mature.

Of the 37 evaluable participants with platinum-resistant ovarian cancer treated at three (3) selected dose levels (50mg BID, 100mg QD and 125mg QD) in the expansion portion of the trial, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer.
In addition, 4 PRs were reported among patients with endometrial cancer.
"The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer. We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination."

The Part 1b data build on results from the dose escalation portion (Part 1a) of the trial evaluating the safety and tolerability of INCB123667 presented during a mini-oral presentation (Mini oral session: Developmental therapeutics) at ESMO (Free ESMO Whitepaper).

Results from the Part 1a dose escalation portion of the trial (data cut-off July 15, 2024) include:

INCB123667 demonstrated a manageable safety profile (n=84). The most common hematologic treatment-related adverse events (TRAEs) were thrombocytopenia (35%, 13% Grade 3), anemia (30%, 7% Grade 3) and neutropenia (26%, 8% Grade 3). The most common non-hematologic TRAEs were nausea (42%), fatigue (23%) and vomiting (17%); all of which were Grade 1 and 2 except one case of Grade 3 vomiting and one case of Grade 3 fatigue.
Strong selective inhibition of CDK2 was observed resulting in circulating tumor DNA (ctDNA) reduction at all dose levels. During dose escalation, 39 out of 48 patients who had ctDNA measurements at cycle 1, day 1 and cycle 2, day 1 showed reductions in ctDNA.
"Results from this study presented today at ESMO (Free ESMO Whitepaper) reinforce the idea that the novel and highly selective CDK2 inhibitor INCB123667 may provide a potential new treatment option for cancers with increased Cyclin E1 signaling (CCNE1 amplification and Cyclin E1 overexpression), predictive of CDK2 dependency," said Dr. Matteo Simonelli, Head of Early-Drug Development in Solid Tumors at IRCCS Humanitas Research Hospital. "The data speak to the potential of INCB123667 as an active and selective targeted therapy for different cancer types, particularly ovarian cancer, and I look forward to seeing further results in later stages of development."

The study is ongoing. Plans are underway to initiate a pivotal study in ovarian cancer next year and evaluate INCB123667 in combination with other treatments.

Conference Call and Webcast Information

Incyte will host an in-person analyst and investor event today from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO (Free ESMO Whitepaper) including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data will include updated results from a later data cut-off, as well as the data included in the ESMO (Free ESMO Whitepaper) accepted abstract and mini-oral presentation.

To access the conference call, please dial 877-407-8037 for domestic callers or +1 201-689-8037 for international callers. When prompted, provide the conference identification number, 13748627.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

About the Trial (NCT05238922)

This open-label, dose-escalation and dose-expansion Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of INCB123667 when administered as monotherapy at the recommended dose for expansion (RDE[s]) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) determined the recommended dose of INCB123667 for expansion and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in six tumor-specific cohorts at the RDEs defined in Part 1A.

For more information about the study, please visit: View Source

About INCB123667

INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models. Cyclin E amplification and overexpression has been reported to be associated with CDK4/6 resistance and poor clinical outcomes in ovarian, gastric, endometrial and breast cancers. INCB123667 has the potential to be a highly targeted and efficacious treatment for advanced solid tumors, including gynecologic tumors, endometrial, uterine, gastric and triple negative breast cancer, among others.

On September 14, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported updates for its T cell receptor (TCR) library targeting the Kirsten rat sarcoma viral oncogene homolog (KRAS) and also highlighted advancements of its UniTope and TraCR technology, which serves as a universal system for tagging and tracking recombinant TCRs (rTCRs) across multiple modalities, including T cell receptor engineered T cell (TCR-T) therapies, at the ESMO (Free ESMO Whitepaper) Congress 2024 taking place in Barcelona from September 13-17, 2024 (Press release, MediGene, SEP 14, 2024, https://www.pressetext.com/news/20240914005 [SID1234646624]).

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The presented posters " Advancing a multi-dimension KRAS mutation-specific T cell receptor (TCR) library with a 3S TCR targeting the G12D mutation to address large global patient populations " and " UniTope & TraCR – Universal tagging and tracking system for TCR-T cells integrated directly in the TCR constant region " will be made available after the conference on Medigene’s website:View Source

"We are excited about our expanding library of mKRAS-specific rTCRs targeting different mutations and HLA allotypes, aiming to broaden treatment options and improve outcomes for patients with difficult-to-treat solid tumors," said Dolores Schendel, CSO at Medigene AG. "Our lead KRAS G12D candidate, enhanced by the costimulatory switch protein (CSP) PD1-41BB, has shown very promising T cell functionality. By overcoming the challenges of the tumor microenvironment that have hindered the effectiveness of TCR-T therapies, we are confident that this program could offer best-in-class efficacy and safety. We are expanding our TCR library and also incorporating new proprietary technologies into our End-to-End (E2E) Platform, including UniTope & TraCR, a universal detection system for any rTCR across various modalities like TCR-T therapies, TCR-guided T cell engagers therapies, and TCR-NK cell therapies. Direct integration of the UniTope tag guarantees 100% co-expression of a unique identifier in a rTCR sequence and provides a significant advancement over current methods for detection of rTCRs in TCR-guided therapeutics. UniTope and TraCR will help us streamline quality control and provide precise data for determining the correct drug dosage for TCR-T therapies."

Advancing a multi-dimension KRAS mutation-specific T cell receptor (TCR) library with a 3S TCR targeting the G12D mutation to address large global patient populations

The first data presented showcased recent advancements in the expansion of the Company’s KRAS library, using a high-throughput approach to develop optimal affinity TCRs targeting the mKRAS G12D neoantigen in the context of HLA-A*11 via Medigene’s proprietary E2E Platform. Further in vitro studies characterized the lead TCR candidate in terms of specificity, sensitivity, and safety (3S) while incorporating the PD1-41BB CSP. TCR-expressing T cells, when stimulated by mKRAS G12D-positive tumor cells, showed increased interferon gamma (IFNγ) release. Reduced cancer cell survival was observed when mKRAS G12D-positive tumor cell lines from various origins were exposed to T cells co-expressing the rTCR mKRAS G12D-HLA-A*11 and PD1-41BB CSP. These effects were specific to mKRAS G12D, with no impact on wild-type KRAS cells. The TCR demonstrated an excellent safety profile, with no off-target toxicity against an extensive panel of healthy cell types. Finally, in vitro data showed that co-expression of PD1-41BB CSP enhanced and sustained T cell function in an rTCR-specific manner, with gated activation that only occurred when the specific peptide-HLA complex was present on target cells, and not through PD-L1 expression alone.

UniTope & TraCR – Universal tagging and tracking system for TCR-T cells integrated directly in the TCR constant region

The second poster displayed the Company´s recently introduced universal TCR tagging and tracking combination technology UniTope & TraCR. Bioinformatic alignment of T cell receptor beta variable sequences enabled a six-amino-acid peptide (UniTope) to be predicted that is not found in natural TCR beta chains and has low immunogenicity. In parallel, an antibody was developed to specifically target this short amino acid peptide (TraCR) and further in vitro experiments demonstrated that TCR-T cells containing the UniTope sequence exhibited similar effects to those of TCR-T cells without the UniTope sequence. Integration of the UniTope sequence in a rTCR guarantees 100% co-expression of the tag and provides a significant advancement over current methods of detection of rTCRs in TCR-guided therapeutics.

In vitro studies confirmed that insertion of UniTope did not alter expression or functionality of rTCRs. In addition, safety assessments confirmed that UniTope-modified rTCRs displayed the same high safety profile as un-modified rTCRs with respect to lack of recognition and killing of 16 healthy cell types.

On September 14, 2024 BioCity reported interim clinical results on the safety and efficacy of its first-in-class antibody-drug conjugate (ADC) BC3195 targeting CDH3 (P-Cadherin) in a Phase I clinical trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (Press release, Biocity Biopharmaceutics, SEP 14, 2024, View Source [SID1234646828]).

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As of the data cut-off date (August 10, 2024), BC3195 demonstrated impressive antitumor activity in patients with advanced non-small cell lung cancer (NSCLC) with an ORR of 36.4% (4 of 11 patients). The ORR was 80% (4 of 5 patients) in NSCLC with epidermal growth factor receptor mutations (EGFRmut). BC3195 demonstrated manageable safety and tolerability, as well as favorable pharmacokinetic characteristics. Dose optimization and further patient accrual in NSCLC, breast cancer, and other types of CDH3-expressing cancers are ongoing. Clinical trial information: NCT05957471.

Thirty-four patients (median age, 59.5; male, 64.7%) have been enrolled at the date of data cut-off, with 3 patients each enrolled at BC3195 dose levels of 0.3, 0.6, 1.2, and 1.8 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W), 21 patients enrolled at the 2.4 mg/kg IV Q3W dose level, and 1 patient enrolled at the 1.2 mg/kg IV weekly dose level.

Notable safety findings include:

All patients in the dose escalation stage of the study were evaluable for dose-limiting toxicity (DLT). One patient had Grade 3 pharyngitis, considered a DLT, following treatment with BC3195 2.4 mg/kg IV Q3W.
Rash, stomatitis and liver function abnormalities were the main adverse events (AEs). Most episodes of rash and stomatitis occurred in the first cycle and were manageable.
Fourteen (41.2%) patients experienced Grade≥3 treatment-related adverse events (TRAEs). Grade ≥3 TRAEs experienced by more than 2 patients include stomatitis (23.5%), neutropenia (8.8%), and rash(8.8%).
Notable efficacy findings include：

Five patients, including 4 NSCLC patients and 1 breast cancer patient had confirmed PRs following treatment with BC3195 2.4 mg/kg IV Q3W.
Of 11 NSCLC patients treated at the 2.4mg/kg IV Q3W dose level, 10 patients had reductions in tumor volume including 4 patients with confirmed PRs and 6 patients with stable disease (SD) as their best response. At 2.4 mg/kg IV, the ORR and disease control rate (DCR) were 36.4% and 90.9%, respectively.
Four of 5 (80%) patients with EGFRm NSCLC had confirmed PRs.
Among the 30 patients who were evaluable for tumor response, no complete response (CR) nor partial response (PR) were reported in BC3195 dose levels up to 1.8 mg/kg IV Q3W.
Based on the promising clinical results already achieved with BC3195, BioCity will continue to collaborate with global researchers to advance the clinical development of this first-in-class ADC.

About BC3195

BC3195 is currently the only ADC targeting CDH3(P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers.

BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and the US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types.

On September 14, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI (Press release, Nuvation Bio, SEP 14, 2024, View Source [SID1234646589]). The findings will be highlighted in a poster presentation on September 14, 2024, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.

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Maurice Perol, M.D., TRUST-II study investigator and Head of Thoracic Oncology at Léon Bérard Cancer Center, commented on the results: "The unmet need for more effective and tolerable treatments for patients with advanced ROS1-positive NSCLC remains critical. The pooled analysis from the TRUST-I and TRUST-II studies reinforces taletrectinib’s potential to offer clinically meaningful advancements in efficacy combined with a favorable safety profile, including reported median duration of response of 44 months and progression-free survival of 46 months in patients who were TKI-naïve."

"We are excited to present compelling pooled data from the TRUST-I and TRUST-II studies at ESMO (Free ESMO Whitepaper), which highlight taletrectinib’s durable response, prolonged disease control, and favorable safety profile. We believe these results position taletrectinib as a potential best-in-class treatment option for people living with advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "These pivotal data will support our planned NDA submission in the fourth quarter of 2024 and, assuming regulatory approval, will enable us to launch taletrectinib in the U.S. in 2025. We are committed to making a positive impact on the lung cancer community and look forward to sharing updates as we continue toward becoming a commercial stage organization."

Summary of Pivotal Pooled Data

The pooled efficacy and safety data from the TRUST-I and TRUST-II studies presented at ESMO (Free ESMO Whitepaper) are as of June 7, 2024; both studies remain ongoing. The ESMO (Free ESMO Whitepaper) data set includes 337 patients with advanced ROS1+ NSCLC who received 600mg of taletrectinib orally once daily in 21-day cycles.

The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, DOR, PFS, and safety.

Significant Tumor Shrinkage and Durability

The pooled efficacy analyses included 160 patients with advanced ROS1+ NSCLC who had not previously been treated with a ROS1 TKI (TKI-naïve) and 113 patients who had previously been treated with crizotinib or entrectinib (TKI-pretreated).

Among these two populations, 94% of patients had stage IV NSCLC. In addition, 20% of TKI-naïve and 37% of TKI-pretreated patients received prior chemotherapy, while 23% of TKI-naïve and 49% of TKI-pretreated patients had brain metastases at baseline.

The efficacy results, independently assessed by an IRC, showed:

In TKI-naïve patients (n=160):

Tumors shrank in 89% of taletrectinib-treated patients (cORR).
Measurable brain metastases shrank in 77% (13/17) of taletrectinib-treated patients (intracranial cORR).
After median follow-up of 21 months, the median DOR and the median PFS were 44 months and 46 months, respectively.
In TKI-pretreated patients (n=113):

Tumors shrank in 56% of taletrectinib-treated patients (cORR).
Measurable brain metastases shrank in 66% (21/32) of taletrectinib-treated patients (intracranial cORR).
Tumors shrank in 62% (8/13) of taletrectinib-treated patients with G2032R mutations (cORR).
After median follow-up of 21 months, the median DOR and the median PFS were 17 months and 10 months, respectively.
Favorable and Consistent Safety Profile Across Studies

The pooled safety analysis included 337 patients with advanced ROS1+ NSCLC. The results demonstrated a favorable safety and tolerability profile, with a low incidence and a limited spectrum of neurologic TEAEs and a low rate of treatment discontinuation.

The most frequent TEAEs were increased aspartate aminotransferase (72%; 8% ≥ Grade 3), alanine aminotransferase (68%; 10% ≥ Grade 3), diarrhea (63%; 2% ≥ Grade 3), and nausea (47%; 2% ≥ Grade 3).

The incidence of neurologic TEAEs was low; the most common were dizziness (21%) and dysgeusia (15%), most of which were Grade 1. The rate of treatment discontinuation due to TEAEs was 7% and the rate of dose reduction due to TEAEs was 29%.

Data Presentation and Availability

The data in the ESMO (Free ESMO Whitepaper) poster from the Response Evaluable Population, which includes all patients with measurable disease who received at least one dose of taletrectinib as of June 7, 2024, form the primary efficacy analysis that will support Nuvation Bio’s planned NDA submission in the United States.

The data in the ESMO (Free ESMO Whitepaper) abstract represent clinical results from patients enrolled at least 14 months before the data cutoff of March 29, 2024.

The poster presentation (abstract #1289P) will take place on Saturday, September 14, 2024, at 12:00-1:00 p.m. CEST / 6:00-7:00 a.m. EDT, and is 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+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ 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 Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1+ 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+ NSCLC who either have or have not previously been treated with ROS1 TKIs.

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 Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of people with NSCLC have ROS1+ disease. Up to 35% of people newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for people with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.

On September 14, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that new data from the GALAXY arm of the ongoing CIRCULATE-Japan trial was released today at the 2024 Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Barcelona, Spain (Press release, Natera, SEP 14, 2024, View Source [SID1234646606]). GALAXY is one of the largest and most comprehensive prospective studies of circulating tumor DNA (ctDNA) testing in resectable colorectal cancer (CRC).

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This latest analysis, which will also be published in Nature Medicine on September 16, provides the first evidence of the ability of Signatera-based molecular residual disease (MRD) detection to predict overall survival (OS). The data also demonstrates Signatera’s ability to predict adjuvant chemotherapy (ACT) benefit in resectable CRC, with ctDNA clearance as an indicator of a superior survival benefit compared to no clearance.

In the study, 2,240 patients with stage II–IV CRC were monitored using Signatera after curative-intent surgery with a median follow-up of 23 months. Key takeaways include:

Signatera status was predictive of overall survival. Signatera-positivity in the post-op MRD window was found to be significantly associated with worse OS compared to Signatera-negative patients (HR: 9.68, p-value < 0.01) with a 36-month OS of 71.80% vs. 96.0%, respectively. This 10x advantage in overall survival compares favorably to all known guideline-recommended biomarkers that have HRs for overall survival in a range of 1-4.
Signatera status was predictive of an overall survival benefit from adjuvant chemotherapy.
High-risk stage II and stage III-IV patients who were Signatera-positive after surgery and received ACT demonstrated superior OS (adjusted HR: 0.53, p-value = 0.05), corresponding to a 50% reduction in the risk of death when treated with ACT. By comparison, the MOSAIC trial1, which was the last practice-changing study in adjuvant CRC, demonstrated a 16% reduction in risk of death (HR: 0.84, p-value = 0.05).
Signatera-negative patients did not derive an OS benefit from ACT (adjusted HR: 0.53, p-value = 0.13).
Signatera status remained the most significant predictor of recurrence. Signatera-positivity after surgery was the single most significant prognostic factor associated with inferior DFS (HR 12.08, p-value <0.01) and OS (HR 9.87, p-value <0.01) in a multivariate analysis that included all clinicopathologic risk factors currently in use. This is also reflected by the 36-month DFS difference between Signatera-positive and Signatera-negative patients at 16.7% (95% CI: 12.1–21.9%) versus 83.5% (95% CI: 81.2%–85.6%), respectively. The association of Signatera-positivity with a significantly increased risk for recurrence was observed across all pathologic stages.
Sustained Signatera clearance after ACT was associated with improved survival. Patients who clear ctDNA and remained Signatera-negative (referred to as "sustained clearance") had superior survival benefit with 24-month OS of 100%. This compares to patients who cleared ctDNA for a period of time but later become Signatera-positive (referred to as "transient clearance"), with 24-month OS of 82%, and patients who did not achieve ctDNA clearance, with 24-month OS of 61%. This finding further supports the utility of sustained ctDNA clearance as a surrogate endpoint for long-term outcomes.
"We now have compelling prospective evidence from a large trial of more than 2,200 patients that clearly reinforces the link between MRD status and overall survival," said Yoshiaki Nakamura, MD, PhD, co-author of the paper and principal investigator of the study from the National Cancer Center Hospital East in Kashiwa, Chiba, Japan. "These findings suggest that Signatera can predict post-surgical outcomes for colorectal cancer patients with great precision, redefining the future of personalized medicine and providing the potential to significantly improve outcomes for a greater number of patients."

"The GALAXY data released today builds on an earlier analysis from the same study that was published in Nature Medicine in 2023," said Minetta Liu, MD, chief medical officer of oncology at Natera. "Introducing 36-month, first-of-its-kind data on overall survival is an important milestone that reinforces the potential to improve outcomes for patients diagnosed with colorectal cancer. The updated data affirms ctDNA status as a critical measure both for prognosis and for predicting which patients may truly benefit from adjuvant chemotherapy."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 70 peer-reviewed papers.