On June 6, 2022 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, and Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that updated efficacy and safety data from the Phase 2 TRUST clinical trial of taletrectinib in patients with ROS1-positive non-small cell lung cancer (NSCLC), at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, AnHeart Therapeutics, JUN 6, 2022, View Source [SID1234615657]).

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The Efficacy and Safety of Taletrectinib in TKI-naïve or Crizotinib-pretreated ROS1-positive Non-Small Cell Lung Cancer (NSCLC) Patients

Poster Presentation, Abstract #: 8572

The ongoing TRUST study (NCT04395677) is a multicenter, open-label, single-arm, Phase 2 study of taletrectinib in Chinese ROS1-positive NSCLC patients who are ROS1 tyrosine kinase inhibitor (TKI)-naive or crizotinib-pretreated.

As of February 23, 2022, the Phase 2 TRUST study has enrolled 67 TKI-naive and 42 crizotinib-pretreated patients. The patients were treated with taletrectinib 600 mg once daily and evaluated by independent review committee (IRC) for key efficacy endpoints including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), intracranial objective response rate (IC-ORR), intracranial disease control rate (IC-DCR), progression-free survival (PFS), overall survival (OS), and safety.

In ROS1 TKI-naïve patients, the cORR was 92.5% (62/67), including 2 confirmed complete response (cCR); and DCR was 95.5% (64/67).
In crizotinib-pretreated patients, the cORR was 50% (19/38), DCR was 78.9% (30/38).
Of the 5 crizotinib-pretreated patients who had ROS1 G2032R mutation, 4 achieved cPR, and 1 achieved SD.
Of the 12 patients with brain metastasis and measurable brain lesions at baseline, the IC-ORR and IC-DCR were 91.7% and 100%, respectively. The brain tumors disappeared completely in one patient who had only non-measurable brain lesions at baseline.
Taletrectinib was generally well tolerated. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2. The most frequently reported treatment-related adverse events (TRAEs) for patients on taletrectinib were low-grade diarrhea and transient AST/ALT elevation without increase in bilirubin. Low incidence of neurological AEs was reported. The selective inhibition of ROS1 over TRKB by taletrectinib may help significantly reduce TRKB-related CNS adverse events. Some common adverse events that are frequently reported in other ROS1 inhibitors, such as vision disorders, edema, headache, dizziness, and musculoskeletal disorders were observed less frequently in taletrectinib.
"Taletrectinib is a potential best-in-class next-generation ROS1 inhibitor that is a much-needed new option to treat both ROS1-TKI-naïve and pre-treated NSCLC patients," said Dr. Caicun Zhou, primary investigator and chief oncologist at Shanghai Pulmonary Hospital. "The TRUST study showed high objective response rates in both the first-line and second-line settings in ROS1-positive NSCLC, with excellent potency against crizotinib-resistant mutations, including G2032R solvent front mutation. We’re excited to see that taletrectinib has also demonstrated intracranial antitumor activity in patients with brain metastases."

"Taletrectinib reported better brain penetration and intracranial activity in reference to other ROS1 inhibitors, with a favorable safety profile," said Dr. Bing Yan, Global Chief Medical Officer and Co-Founder of AnHeart. "We look forward to advancing taletrectinib, as we believe it is a potential best-in-class next-generation ROS1 inhibitor for both ROS1 TKI-naïve and ROS1 TKI-pretreated NSCLC patients, who are in need for new therapeutic options that have antitumor activity against resistant mutations and brain metastases."

"The updated ORR and DCR data of taletrectinib demonstrated its potential superior benefits in terms of both efficacy and safety for Chinese patients with ROS1-positive NSCLC," said Dr. Hui Zhou, Senior Vice President of Innovent. "We are encouraged by the results and will move towards further clinical development of taletrectinib to explore the potential of the next-generation ROS1 inhibitor and benefit more NSCLC patients in the future."

ROS1 oncogenic fusions are observed in ~1-2% NSCLC patients as well as in cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. CNS metastasis occurs in 20-30% ROS1 TKI-naïve and in up to 50% of crizotinib-pretreated ROS1-positive NSCLC patients. Resistance to first-generation ROS1 inhibitors often occurs with secondary mutations such as ROS1 G2032R solvent front mutation, for which no FDA-approved therapy is available.

Taletrectinib is a next-generation, CNS-penetrant, selective ROS1 inhibitor. In March 2022, the NMPA grants Breakthrough Therapy Designation (BTD) to taletrectinib for both first-line TKI-naïve and second-line TKI-pretreated patients with ROS1-positive NSCLC.

A separate global Phase 2 trial TRUST-II (NCT04919811) is actively enrolling patients at clinical sites in North America, Europe and Asia. The design of the TRUST-II study is presented in the poster (#TPS8601) at ASCO (Free ASCO Whitepaper) 2022.

ABOUT TALETRECTINIB

Taletrectinib1 is a novel best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at View Source For questions about the ongoing trials, please contact [email protected].

On June 6, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Company presented two posters with study results for CT041, an autologous CAR T-cell product candidate against protein Claudin18.2 (CLDN18.2) (Press release, Carsgen Therapeutics, JUN 6, 2022, View Source;301561407.html [SID1234615673]). The two posters included (1) results from the multicenter Phase 1b CT041 trial in the U.S. for patients with advanced gastric and pancreatic adenocarcinoma and (2) the safety and preliminary efficacy results from the Phase Ib/II CT041 study in China for patients with advanced gastric/gastroesophageal junction adenocarcinoma.

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The abstracts of the posters are listed below:

Abstract #2538: Multicenter Phase 1b Trial of Salvage CT041 CLDN18.2 – specific Chimeric Antigen Receptor T Cell Therapy for Patients with Advanced Gastric and Pancreatic Adenocarcinoma

A single-arm, open-label, Phase 1b trial (NCT04404595) was conducted in six centers in the U.S. CLDN18.2 positive patients who had gastric cancer or gastroesophageal junction cancer (GC/GEJ) with ≥ 2 prior lines of systemic therapy or pancreatic cancer (PC) with ≥ 1 prior line were eligible for the study. A preconditioning regimen with fludarabine, cyclophosphamide, and nab-paclitaxel (100 mg or 100 mg/m2; FNC) was given prior to CT041 infusion. Adverse events (AEs) were graded per CTCAE v5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded by ASTCT criteria. Tumor response was assessed per RECIST 1.1.

As of May 6, 2022, 14 patients had enrolled (5 GC/GEJ, 9 PC) with a median of 3 prior lines of therapy (range 1-5) and had received 18 total cycles of CT041. Fourteen patients were given by three dose levels (DL) including DL1 of 2.5-3.0×108 cells (n=6), DL2 of 3.75-4.0×108 cells (n=6) and DL3 of 6.0×108 cells (n=2).

Safety

No dose-limiting toxicities or treatment-related deaths were observed. No ≥ Grade 3 CRS or ICANS was observed. No gastrointestinal bleeding or acute gastric mucosal injury were reported. One patient did not have CRS. Among the 13 patients with CRS, 11 patients had Grade 1 and 2 patients had Grade 2.

Efficacy

In a subgroup of patients with GC/GEJ, an objective response rate (ORR) of 60% was reported, and one patient achieved complete response (CR). Additionally, tumor shrinkage was observed in 80% (4 of 5) of patients with stable disease (4 patients with PC). Median duration of response (mDOR) and progression-free survival (mPFS) have not been reached. Two patients who received DL3 did not have tumor response assessments by the data cutoff date. Dose-dependent responses were observed in DL1 and DL2. An ORR of 16.7% and a disease control rate (DCR) of 50% was observed in DL1. An ORR of 33.3% and a DCR of 83.3% were observed in DL2. Tumor response details are listed in the table below.

Tumor response by tumor type

GC/GEJ (n=5)

n (%)

PC (n=7)

n (%)

Complete response

1 (20)

0 (0)

Partial response

2 (40)

0 (0)

Stable disease

1 (20)

4 (57.1)

Progressive disease

1 (20)

3 (42.9)

Note: GC/GEJ= gastric cancer or gastroesophageal junction cancer; PC=pancreatic cancer.

Conclusion

In heavily pre-treated gastric cancer, CT041 CLDN18.2 CAR T cells may have significantly improved antitumor activity compared to historical treatment regimens.

Abstract #4017 Safety, Tolerability and Preliminary Efficacy Results in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma from a Phase Ib/II Study of CLDN18.2 CAR T-cell Therapy (CT041)

This multicenter, open-label, Phase Ib/II study (NCT04581473) was conducted to evaluate the safety and efficacy in Chinese patients with GC/GEJ. In Phase Ib, CT041 dose levels of 2.5×108 and 3.75×108 cells were investigated using a 3 + 3 design.

Key eligibility criteria for the Phase Ib study: patients with CLDN18.2-positive expression confirmed by immunohistochemistry (IHC) staining (2+/3+ in ≥40% tumor cells), advanced GC/GEJ adenocarcinoma who were refractory to or intolerant of at least 2 prior treatments are eligible for this study. HER2–positive patients should have received standard anti–HER2 therapy.

As of December 22, 2021, 14 eligible patients with GC/GEJ were enrolled in Phase Ib, among which 57.1% had ≥ 3 metastatic organs and 92.9% had peritoneal dissemination. Most of the patients (85.7%) had received 2 prior treatments or a triple combination of fluoropyrimidine, oxaliplatin and paclitaxel. 35.7% of the patients had been exposed to PD-1/PD-L1 inhibitor. The baseline characteristics are shown in the table below.

Demographics and baseline characteristics

Total (N = 14)

Median age (range), year

44.5 (23–71)

Male, n (%)

6 (42.9%)

Eastern Cooperative Oncology Group performance status=1, n (%)

12 (85.7%)

Lauren classification, n (%)

Intestinal type

3 (21.4%)

Diffuse type

9 (64.3%)

Mixed type

2 (14.3%)

Signet ring cell carcinoma, n (%)

9 (64.3%)

Claudin18.2 staining, n (%)

2+

2 (14.3%)

3+

12 (85.7%)

HER2 expression, n (%)

Positive

1 (7.1%)

Negative

12 (85.7%)

Unknown

1 (7.1%)

Numbers of metastatic organs, n (%)

< 3

6 (42.9%)

≥ 3

8 (57.1%)

Peritoneal metastasis, n (%)

13 (92.9%)

Liver metastasis, n (%)

3 (21.4%)

Numbers of prior lines, n (%)

2*

12 (85.7%)

≥ 3

2 (14.3%)

Prior systemic therapies, n (%)

Fluorouracil

14 (100%)

Platinum

14 (100%)

Paclitaxel / nab–paclitaxel

13 (92.9%)

PD–1/PD-L1 inhibitor

5 (35.7%)

Tyrosine–kinase inhibitor

2 (14.3%)

* Five patients received a triple combination of fluoropyrimidine, oxaliplatin and paclitaxel as first line treatment.

All 14 patients received 1 cycle of bridging chemotherapy determined by the investigators, including 13 patients (92.9%) received FOLFIRI, and only 1 received 5–FU plus intraperitoneal nab–paclitaxel. All patients received preconditioning treatment (fludarabine 25 mg/m2 on d1–2, cyclophosphamide 250 mg/m2 on d1–3 and nab–paclitaxel 100 mg on d2) before CT041 infusion. All patients received at least one infusion (11 received 2.5×108 cells and 3 received 3.75×108 cells) of CT041 and 7 patients received two infusions. For the 7 patients who received two infusions, the median interval between infusions was 132 days (range 49–252 days).

Safety

No patients had dose–limiting toxicities or AEs leading to death. Thirteen patients had Grade 2 CRS, and only one patient had Grade 4 CRS, which was related to the patient’s disease burden, who fully recovered after corticosteroid treatment. No ICANS or gastrointestinal mucosal injury were reported.

Efficacy

Thirteen patients were evaluable and one patient withdrew from the study before any tumor assessment was performed. Eight of 14 (57.1%) patients achieved partial response at the first tumor assessment after the first CT041 infusion. Based on the investigators’ assessment, the ORR and DCR were 57.1% and 78.6% respectively.

While the median follow-up time was 8.8 months, the mPFS and median overall survival were 5.6 months and 10.8 months respectively. Seven patients were still alive by the cutoff date.

Conclusion

These preliminary results suggest that CT041 had manageable safety/tolerability profile and promising efficacy in patients with previously treated advanced GC/GEJ adenocarcinoma. This study is ongoing with further investigation of CT041 in confirmatory Phase II underway.

Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics Holdings Limited, said, "Solid tumors, including gastric cancer, are of high incidence globally. As treatment options for gastric cancer are still limited, there is a strong need for more innovative therapies. The updated clinical data of CT041 at ASCO (Free ASCO Whitepaper) 2022 are very encouraging in pre-treated GC/GEJ and PC patients, demonstrating significant efficacy and excellent tolerability, including the impressive ORR of 60% and a case of CR. We look forward to the continuing development of CT041 and we believe it can help more patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "It is the first time that we presented the data for CT041 from registrational trials in China and the U.S. Following the publication of the results of an investigator-initiated trial of CT041 in Nature Medicine earlier in May, the updated results announced at ASCO (Free ASCO Whitepaper) 2022 further demonstrated the promising therapeutic efficacy and favorable safety of CT041. CT041 is currently the only CAR T-cell product candidate entering a confirmatory Phase II clinical trial for the treatment of solid tumors. We will spare no efforts to continue driving the global clinical development of CT041 to benefit more cancer patients worldwide."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on GC/GEJ and PC. CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide.

As of the date of the announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND/CTA approvals from the FDA, the NMPA and Health Canada.

Active trials in CARsgen include investigator-initiated trials, a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

In May 2022, the phase I trial interim results of an investigator-initiated trial of CT041 have been published in Nature Medicine. In this largest clinical trial for solid tumors to date, the CAR T-cell therapy showed unprecedented efficacy against solid tumors.

In 2020 and 2021, CT041 received Orphan Drug designation from the U.S. FDA for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA for the treatment of advanced gastric cancer. In November 2021, CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced gastric cancer. In January 2022, CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by U.S. FDA for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors.

On June 6, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 10:30 a.m. ET (Press release, Tempest Therapeutics, JUN 6, 2022, View Source [SID1234615625]).

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To access the live or archived recording of the company presentation, please visit the investor section of the Tempest website at View Source

On June 6, 2022 Molecular Templates, Inc., (Nasdaq: MTEM, "Molecular Templates" or "MTEM") a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported highlights from the two poster presentations on its clinical programs that were presented on June 5th at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place June 3 through June 7, 2022 at the McCormick Place Convention Center in Chicago, IL (Press release, Molecular Templates, JUN 6, 2022, View Source [SID1234615641]). Copies of the posters presented at ASCO (Free ASCO Whitepaper) can be found in the "Investors" section of Molecular Templates’ corporate website under Presentations.

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"ETBs offer novel biology with the potential to drive unique clinical outcomes, even against well-explored targets," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We are seeing differentiated pharmacodynamic effects and signs of clinical benefit in patients in our on-going Phase I study with MT-6402, our PD-L1 targeting agent, from both that agent’s direct cell-kill effects and its antigen seeding ability. For MT-5111, our HER2-targeting agent, we have achieved exposures in dose-escalation with which have generated pharmacodynamic effects that may be associated with clinical benefit."

Poster Title: First-in-human, dose escalation and expansion study of MT-6402, a novel engineered toxin body (ETB) targeting PD-L1, in patients with PD-L1 expressing relapsed/refractory advanced solid tumors: Interim Data

Authors: Eugene Ahn, MD; Brian Van Tine, MD; John D. Powderly, MD; Herbert L. Duvivier, MD, JD; Drew Rasco, MD; Agnes Rethy, MD; Chris Moore, PhD; Amy Yuet, PhD; Rachael M. Orlandella, PhD; Swati Khanna, PhD; Joseph D. Dekker, PhD; Angela Georgy, PharmD; David R. Spigel, MD

Abstract #: 2521

Poster highlights:

Data were presented on 12 patients with PD-L1+ relapsed/refractory disease across two dose cohorts: 16 mcg/kg (n=6) and 24 mcg/kg (n=6). Treatment is on-going in the 32 mcg/kg cohort with no dose-limiting toxicities (DLTs) observed to date in the third cohort.
Pharmacodynamic (PD) effects including PD-L1+ dendritic cell and monocyte cell depletion and T cell activation have been observed in the majority of patients. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg cohort generally showing a more rapid and profound PD effect. Patients in both cohorts demonstrated increases in IL-2.
One patient in the first cohort with non-small cell lung cancer (NSCLC) (osseous non-measurable disease only) that had progressed after prior checkpoint therapy (PD-1 and CTLA-4) showed qualitative reduction in tumor burden.
One DLT was observed in a single patient (24 mcg/kg) who experienced dermatitis that resolved rapidly with systemic steroids. The patient was rechallenged without incident at 24 mcg/kg. No other DLTs have been reported.
Based on these findings, monotherapy will continue to be investigated and a combination approach with a PD-1 inhibitor is also being considered for select populations of patients.
Poster Title: A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results

Authors: Brian A. Van Tine, MD, PhD; Joleen M. Hubbard, MD; Monica M. Mita, MD; Minal A. Barve, MD; Erika P. Hamilton, MD; Frances Valdes, MD; Daniel Ahn, DO; Joshua Pelham; Admasu Mamuye, MD; Amy Yuet, PhD; Diana Yurewicz, MPH; Yanning Liu, PhD, Taunya Smith, MPH; Andrés Machado Sandri, MD; William J. Edenfield, MD; Aki Morikawa, MD, PhD; Meena Okera, MD; Zev A. Wainberg, MD

Abstract #: 2583

Poster highlights

Data were presented on 35 patients with HER2+ relapsed/refractory disease across eight dose cohorts ranging from 0.5 mcg/kg to 13 mcg/kg (N=31) and the breast cancer expansion cohort (N=4): Treatment is on-going with the 17 mcg/kg cohort having been closed and dosing has begun in the 23 mcg/kg cohort.
No Grade 4 or 5 treatment emergent adverse events or DLTs have been identified in 35 patients, including 2 patients who were treated for 6 months or longer.
Serum concentration of MT-5111 showed predictable and dose-proportional increasing exposure in the last three evaluable dose cohorts.
Higher MT-5111 doses (6.75 mcg/kg and above) appear to saturate circulating soluble HER2 (sHER2) receptors with patients’ HER2 levels stabilizing or decreasing at higher doses.

On June 6, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported that the study design of the NHS-Galleri trial was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Grail, JUN 6, 2022, View Source [SID1234615658]). The poster, titled "NHS-Galleri Trial Design: Equitable Study Recruitment Tactics for Targeted Population-Level Screening With a Multi-Cancer Early Detection (MCED) Test," was presented by Professor Charles Swanton, MD, PhD, a cancer researcher and oncologist at University College London and the Francis Crick Institute, chief clinician, Cancer Research UK, and co-chief investigator of the study (Abstract #TPS6606).

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The NHS-Galleri trial is a randomized and controlled clinical trial in the NHS’ clinical practice setting. It is the largest study of an MCED test, enrolling 140,000 healthy volunteers aged 50-77 in select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years. Regions in the UK were selected to include areas of high cancer mortality, socioeconomic deprivation and ethnic diversity, using innovative methods to enroll a study population with a reasonable number of participants from all socioeconomic groups and major ethnic minority groups.

The study’s aim is to determine if the Galleri test, along with other standard cancer screenings, can find cancers at an early stage when they are less advanced, and patients have a higher chance of successful and potentially curative treatment. It will assess absolute numbers of stage 3 and 4 cancers diagnosed at 3.5 years following randomization.

"This study has the potential to be game changing for early cancer detection, as we evaluate an unprecedented number of healthy volunteers and work to ensure participants are representative of the entire population with cancer," said Dr. Swanton. "Unfortunately, many cancers are found too late, when they are more advanced and difficult to treat. We know early diagnosis saves lives, and we think this test could be a key to increasing cancer survival rates for more people."

The collaboration between GRAIL and the NHS supports the NHS Long Term Plan to transform cancer care with three in four cancers diagnosed at an early stage by 2028. More than 100,000 participants have been enrolled to date. Enrollment is expected to be completed in July 2022, and initial trial results are expected in 2024. If successful, the NHS plans to extend the rollout to an additional 1 million people in 2024 and 2025.

"We share a commitment with the NHS to have data that is representative of society at-large and all people with cancer and ensuring that access to cancer screening and earlier diagnosis is accessible and equitable," said Josh Ofman, MD, MSHS, president, GRAIL. "The current approach for screening and diagnosing cancer is not as effective as it could be and we are committed to changing the status quo. We are proud to be working with the NHS on this groundbreaking, large-scale, population screening program that has the potential to fundamentally transform early cancer detection."

In a clinical study, the Galleri test demonstrated the ability to detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 47 of which lack recommended screening tests today in the UK. GRAIL’s Galleri test has a false positive rate under 1% and it can predict where cancer originated with 89% accuracy.

"We applaud the UK Government and the NHS for their leadership in setting the roadmap to achieve their goal of diagnosing three-quarter of all cancers at an early stage by 2028," said Sir Harpal Kumar, president of GRAIL Europe. "A reduction in late-stage cancer is thought to precede a reduction in deaths and is also associated with other beneficial patient outcomes, including the ability to receive effective therapy and improve quality of life."

About NHS-Galleri trial

For the prospective, partially blinded, randomized trial, all study participants will provide a blood sample during three annual visits to a mobile health clinic—at baseline, year 1 and year 2. After the first visit, participants are randomized 1:1 into either the intervention or control arm. Participants in the intervention arm will have their blood tested by the Galleri test. Blood samples from subjects in the control arm will not be tested immediately, but will be stored for potential future testing. If a cancer signal is detected for those in the intervention arm, research staff will explain the result and schedule an appointment for follow-up tests at an NHS hospital local to the participant. All participants in the study will be followed for cancer and other related outcomes via NHS databases and will be reminded to continue to have guideline-recommended cancer screenings.

The study is sponsored by GRAIL and is being run by Cancer Research UK and King’s College London Cancer Prevention Trials Unit (UK), in collaboration with eight cancer alliances in England.