On November 29, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported the transfer of the IND for letetresgene autoluecel (lete-cel) from GSK to Adaptimmune for the pivotal IGNYTE-ESO (NCT03967223) clinical trial (Press release, Adaptimmune, NOV 29, 2023, View Source [SID1234638053]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The compelling clinical data from the pivotal IGNYTE-ESO trial frames lete-cel as the ideal synergistic product to afami-cel and could enable our sarcoma franchise to more than double the addressable patient population. Further, we can deliver lete-cel to market efficiently using the same commercial footprint we intend to use for afami-cel."

Adaptimmune recently reported data from a protocol-defined interim analysis of the pivotal IGNYTE-ESO trial. In this analysis, 40% (18/45) of people with synovial sarcoma or myxoid/ round cell liposarcoma (MRCLS) had confirmed clinical responses with lete-cel by independent review. The primary efficacy endpoint requires 16/60 patients have responses. As a result, the Company is evaluating the integration of lete-cel into its sarcoma franchise and is looking forward to sharing its development plans for lete-cel in the new year.

Lete-cel, an engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1, was originally developed by Adaptimmune, and further developed under a collaboration and license agreement with GSK plc. Lete-cel is being investigated for the treatment of synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) in the pivotal IGNYTE-ESO (NCT03967223) trial in patients who received prior anthracycline treatment. In 2023, Adaptimmune and GSK agreed terms regarding the return of the NY-ESO program back to Adaptimmune. Per the terms of the Agreement, Adaptimmune has received an upfront amount and will receive milestone-based payments totaling £30 million in relation to the transfer of the clinical trials for the NY-ESO targeted programs.

About synovial sarcoma

There are approximately 50 types of soft tissue sarcomas which are categorized by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5% to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the U.S. each year).2 One third of patients with synovial sarcoma will be diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is just 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.3

1. View Source accessed Oct. 24, 2023
2. Synovial Sarcoma – NCI (cancer.gov) accessed Oct. 24, 2023
3. Aytekin MN, et al. J Orthop Surg (Hong Kong). 2020;28(2)

About Myxoid/round cell liposarcoma (MRCLS)

Myxoid/round cell liposarcoma (MRCLS) is a type of soft tissue sarcoma that is predominantly found in the limbs. MRCLS accounts for approximately 5% to 10% of all soft tissue sarcomas.1 One-third of MRCLS cases will become metastatic with tumors spreading to unusual bone and soft tissue locations. MRCLS commonly presents at an age ranging from 35-55 years and has a poor prognosis because it recurs locally and tends to metastasize quickly and widely. The 5-year survival rate for metastatic MRCLS is only 5%.2

1. View Source accessed Oct. 24, 2023
2. https: www.orpha.net accessed Oct. 24, 2023

Overview of IGNYTE-ESO trial design

IGNYTE-ESO is a Phase 2, open-label trial for people with advanced synovial sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability of lete-cel. Lete-cel’s engineered TCR T-cells target NY-ESO-1+ tumors. NY-ESO-1 is highly expressed in synovial sarcoma and MRCLS in the context of HLA-A*02.

Key eligibility criteria include ECOG performance status of 0 or 1; HLA*02 positive with confirmed NY-ESO expression in ≥ 30% of tumor cells ≥ 2+ by immunohistochemistry; aged ≥ 10 years; and patients must have measurable disease according to RECIST v1.1 at the time of treatment. The IGNYTE-ESO master protocol include two substudies – Substudy 1 was designed to investigate lete-cel in previously untreated advanced (metastatic or unresectable) synovial sarcoma or MRCLS; and Substudy 2 was designed to investigate lete-cel in advanced (metastatic or unresectable) synovial sarcoma or MRCLS post-anthracycline chemotherapy. Eligible patients received lete-cel doses between 1-15 × 10^9 transduced T-cells after receiving lymphodepleting chemotherapy.

Approximately 10 people were planned to be treated in Substudy 1, 5 patients were treated and enrollment was stopped. Approximately 60 people were planned to be treated in Substudy 2 and enrollment is complete.

On November 29, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that an abstract exploring the long-term impact of trilaciclib on survival outcomes in patients with metastatic triple negative breast cancer (mTNBC) from the Company’s Phase 2 trial (NCT02978716) will be presented in a poster session during the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th through 9th in San Antonio, TX (Press release, G1 Therapeutics, NOV 29, 2023, View Source [SID1234638052]). A copy of the poster will be made available on the G1 Therapeutics website following the presentation here.

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Results in the poster include:

Median overall survival (OS) for patients who received subsequent lines of anticancer therapy (SACT) after discontinuation of study treatment was 32.7 months for patients who had previously received trilaciclib prior to gemcitabine/carboplatin (GCb) compared to 12.8 months for patients who had previously received GCb only (no trilaciclib), with increasing separation of survival curves over time.
Improved survival and sustained separation of curves was also observed in patients unable to receive SACT, although the magnitude of benefit was smaller (median 9.4 months for patients who had previously received trilaciclib vs 5.4 months for patients who had previously received chemotherapy alone).
Notably, median OS from the start of the first SACT was 14.0 months in patients who had previously received trilaciclib prior to GCb compared to 5.8 months in patients who received GCb only (no trilaciclib).
For patients who received any SACT after discontinuation of study treatment, demographics and clinical characteristics including, time from end of study treatment to first SACT, and type of SACT were balanced between the prior trilaciclib (n=43) and prior GCb-only (n=20) groups.
"These results describe the long-term survival benefits of treatment with trilaciclib in patients with triple negative breast cancer that participated in our Phase 2 trial," said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics. "The survival benefit appears to extend well beyond the initial treatment with trilaciclib and chemotherapy. Importantly, patients who had previously received trilaciclib continue to benefit with subsequent therapies, resulting in substantially longer survival than patients who had previously received chemotherapy alone. We believe this is likely due to preservation of bone marrow and immune function, resulting in improved long term immune surveillance. We look forward to sharing these results with the oncology community, as we assess the impact of trilaciclib on overall survival in our ongoing pivotal Phase 3 mTNBC and Phase 2 ADC trials."

Poster Presentation Details:
Patients With Metastatic Triple-Negative Breast Cancer who Receive Trilaciclib Prior to Cytotoxic Chemotherapy Exhibit Improved Survival After Receiving Subsequent Anticancer Therapy. O’Shaughnessy, J. et al.
Presentation ID (poster and abstract number): PO2-06-12.
Poster Session 2
Wednesday, December 6, 2023. 5:00 PM – 7:00 PM CDT

On November 29, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that clinical validation data published in the journal CHEST show that the company’s Percepta Nasal Swab test determines lung cancer risk, with high accuracy, among people who currently smoke or have previously smoked and have lung nodules (Press release, Veracyte, NOV 29, 2023, View Source [SID1234638049]). The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.

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Lung cancer is the leading cause of cancer death worldwide. Lung nodules are an early indicator of lung cancer and are typically found using computed tomography (CT) scans. In the United States, approximately 15 million people are eligible for annual lung cancer screening with low-dose CT scans based on their smoking history and other factors and currently an estimated 1.6 million lung nodules are found incidentally each year in patients being evaluated with a CT scan for an unrelated condition. While most lung nodules are not cancerous, their detection can result in unnecessary diagnostic procedures and anxiety for patients. At the same time, early detection of cancerous nodules can lead to better patient outcomes.

"Physicians need an objective, accurate tool to help guide care for patients when a lung nodule is found on a CT scan," said Bill Bulman, M.D., Veracyte’s medical director for Pulmonology and an author on the CHEST manuscript. "Our findings reinforce the ability of the Percepta Nasal Swab test to improve risk assessment of lung nodules and help avoid unnecessary diagnostic procedures for those at low risk of cancer while supporting timely diagnosis and treatment for those with high risk of cancer."

Veracyte’s Percepta Nasal Swab test is a simple, non-invasive genomic test that can be done in the physician’s office and is designed to assess lung cancer risk in patients who currently smoke or have previously smoked and have lung nodules found on CT scans. The test reports whether a patient has a high-, moderate- or low-risk for lung cancer, providing insights to help physicians objectively determine which patients with lung nodules to work up for lung cancer and which patients to simply monitor with imaging.

For the CHEST study, researchers used the Percepta Nasal Swab test, which was trained on a cohort of 1,120 patients with lung nodules that were either malignant or benign, to evaluate nasal samples from an independent cohort of 312 eligible patients followed for at least 12 months or until a final diagnosis of benign or malignant was determined.

Results show that the Percepta Nasal Swab test is highly accurate in identifying patients with low-risk nodules (97% sensitivity, with 40% specificity). This high sensitivity provides a negative predictive value, or NPV, of 98% in a population with a 25% cancer prevalence, meaning the test could assist physicians in avoiding unnecessary invasive procedures in patients with a benign nodule, with a very small risk of missing a cancer.

Similarly, researchers found that the test is highly accurate in identifying patients with high-risk nodules (92% specificity, with 57% sensitivity). This high specificity provides a positive predictive value, or PPV, of 70% in a population with a 25% cancer prevalence, meaning the test could assist physicians in directing these patients to further procedures so they could obtain an accurate diagnosis and speed time to treatment, if necessary.

The Percepta Nasal Swab test had consistently high performance across various groups of patients within the study cohort, including those with prior cancers and different lung cancer subtypes, lung nodule sizes (including nodules <8 mm), smoking histories and lung cancer screening eligibility, suggesting the test’s potential clinical value in a wide range of patients. In contrast, currently available physician risk calculators were developed with specific patient populations in mind and tend to perform unevenly across different types of patients.

"We believe our Percepta Nasal Swab test can be paradigm-changing in the evaluation of lung cancer risk among patients with lung nodules," said Dr. Bulman. "By helping to guide next steps for physicians and their patients, we aim to help make lung nodule evaluation, including through lung cancer screening programs, more efficient and effective."

Publication of the Percepta Nasal Swab test clinical validation study is an important step in Veracyte’s journey toward securing payer reimbursement for the test, prior to the test being made widely available. Additionally, the company is currently conducting a prospective clinical utility study, known as NIGHTINGALE, at hospitals and clinics around the United States to demonstrate the test’s ability to improve patient care and outcomes.

The Percepta Nasal Swab test was developed with RNA whole-transcriptome sequencing and machine-learning technology. It utilizes foundational "field of injury" science, which evaluates genomic changes associated with lung cancer that can be found in epithelial cells in the nasal passages of current and former smokers.

On November 29, 2023 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported that management will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference, taking place in Miami, Florida on Thursday, November 30, 2023 at 8:45 a.m. ET (Press release, SpringWorks Therapeutics, NOV 29, 2023, View Source [SID1234638048]).

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To access the live webcast please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On November 29, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy has been reached (Press release, Sellas Life Sciences, NOV 29, 2023, View Source [SID1234638046]).

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"Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are extremely grateful to the participating patients and investigators who have helped achieve this critical milestone and we look forward to sharing the interim analysis which we expect to occur by the end of this year or early next year based upon our statistical assumptions. We are also looking forward to the upcoming IDMC meeting later this month. REGAL is the most comprehensive study conducted by a biotech company to date in this orphan disease setting. With a strong scientific rationale and supportive clinical data in previously conducted Phase 1 and Phase 2 studies in the AML maintenance setting, we believe GPS holds significant promise as a potential new treatment for AML patients. Furthermore, the positive outcome from the recently completed FDA Type C meeting and FDA’s guidance on the advancement of our CMC plans for a BLA filing, assuming positive results from the REGAL study, further strengthens our overall GPS program."

The Phase 3 open-label REGAL trial was designed with formal input from the United States Food and Drug Administration. Over 100 patients have been enrolled in the United States, Europe and Asia in the study which compares GPS monotherapy in the maintenance setting to investigators’ choice of best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is overall survival (OS) from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples.

Based upon the Company’s statistical assumptions, the interim analysis (after 60 events) is expected to occur in late 2023 or early 2024 and the final analysis (after 80 events) is on track to occur by the end of 2024. Because these analyses are event driven, they may occur at a different time than currently expected.

GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.

For more information on the REGAL Phase 3 trial of GPS for the treatment of AML, please visit ClinicalTrials.gov and reference Identifier NCT04229979.