On May 23, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the release of abstracts on alisertib to be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, MAY 23, 2024, View Source [SID1234643650]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held at McCormick Place in Chicago and online from May 31-June 4.

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Full abstracts of the following posters are available online at View Source

Abstract 1037: Molecular profiling of serial liquid biopsy specimens utilizing cell free DNA (cfDNA) and circulating tumor cells (CTCs) in TBCRC 041: A phase II study of alisertib in endocrine resistant metastatic breast cancer (MBC)
Presenter: Karthik Giridhar, MD., Mayo Clinic
Abstract 8572: Phase I/Ib study of the aurora kinase A Inhibitor alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer
Presenter: Turja Chakrabarti, MD., University of California, San Francisco

On May 23, 2024 Flatiron Health reported its significant presence at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago this June (Press release, Flatiron Health, MAY 23, 2024, View Source [SID1234643649]). Nine abstracts led by Flatiron have been accepted for poster presentation and online publication. A comprehensive of all accepted research using Flatiron data is available via ASCO (Free ASCO Whitepaper)’s website.

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Aligned with the conference theme, ‘The Art and Science of Cancer Care: From Comfort to Cure,’ Flatiron is dedicated to spearheading evidence generation in oncology. This year’s accepted research reflects that dive into critical touch points across the oncology ecosystem.

"At Flatiron, we’re pioneering new approaches to address health equity, enhance clinical trials, and bridge the gap between routine care and research," stated Neal Meropol, VP of Research Oncology, Flatiron Health. "Through innovative methodologies and real-world evidence, we’re generating insights to improve cancer treatment and care delivery on behalf of patients. By seamlessly integrating science, technology, and medicine, we aim to deliver impactful results in collaboration with our partners."

This year’s accepted abstracts once again showcase Flatiron’s commitment to collaboration and partnership in pursuit of its mission to improve and extend lives by learning from the experience of every person with cancer.

Highlights include:

A study employing machine-learning models across a nationwide cohort to explore practice patterns in the face of chemotherapy shortages.
A study exploring the role of biomarkers in guiding treatment for metastatic breast cancer, focusing specifically on patients with HR+/HER2- tumors.
A study examining how structural racism and social determinants of health contribute to inequities in endometrial cancer care, particularly among patients with advanced disease.
Schedule a meeting with Flatiron Health at ASCO (Free ASCO Whitepaper) 2024, and learn more about our abstracts and events, including workshops and panels.

Follow Flatiron Health on Twitter and LinkedIn for more updates and visit us in person at Booth #11123.

Poster Presentations

Impact of carboplatin and cisplatin shortages on treatment patterns in patients with metastatic solid tumors
Emily Castellanos, Qianyu Yuan, Niquelle Brown Wadé, Khilna Patel, Catherine Rinaldi, Samantha Reiss, Eunice Hankinson, Aaron Cohen, Melissa Estevez
Abstract #: 11149
Poster Bd #: 344

Real-world ctDNA testing patterns, associated biomarkers and sites of metastasis in early stage colorectal cancer
Erin Fidyk, Laurynas Kalesinskas, Konstantin Krismer, Auriane Blarre, Lilia Bouzit, John Ritten, Anca Marinescu, Jonathan Kelly, Katherine Harrison, Aaron Cohen
Abstract #: 3610
Poster Bd #: 273

Testing patterns and prevalence of PIK3CA, AKT1, and PTEN alterations among patients with HR+/HER2- metastatic breast cancer in the US
Partners: AstraZeneca, Biometrics Oncology, MD Anderson Cancer Center
Leak Park, Samantha Thompson, James Roose, Yichen Lu, Moumita Chaki, Clara Lam, J. Bryan Lorgulescu
Abstract #: 1041
Poster Bd # 19

Racial/ethnic inequities in care for patients with advanced endometrial cancer: what’s structural racism and social determinants of health got to do with it?
Cleo A. Ryals, Gene G. Ho, Khilna Patel, Amy Pierre, Mustafa S. Ascha, Taavy A. Miller, Olive Mbah
Abstract #: 1602
Poster Bd #: 473

The BEV1L study: do real-world outcomes associated with the addition of bevacizumab to first-line chemotherapy in patients with ovarian cancer reinforce clinical trial findings?
Partners: GSK and University of Virginia
Linda Duska, Jonathan Lim, Tirza Areli Calderón Boyle, Mark Guinter, Siobhan Halloran, John Hartman, Jeanne M. Schilder, Jean A. Hurteau, Amanda Golembesky
Abstract #: 5563
Poster Bd #: 434

Real-world treatment patterns and outcomes by mismatch repair/microsatellite instability (MMR/MSI) status in patients with advanced endometrial cancer, 2018-2023
Partners: AstraZeneca, YU Langone Health, and Washington University School of Medicine
Premal H.Thaker, Bhavana Pothuri, Olga Tymejczyk, Samantha Reiss, Giovanni Nitti, Theresa Cain, Manila Hada
Abstract #: 5601
Poster Bd #: 472

Online Publications

Utility of automated data transfer for cancer clinical trials
Partners: MD Anderson and Washington University in St. Louis
Ivy Altomare, Addison Shelley, Yichen Lu, Paul Salcuni, Nicole Graves, Abhishek Maiti, Ramaswamy Govindan
Abstract: e23011

Characterization of cancer clinical trials in the community setting
Partners: ACCC, City of Hope, and Penn Lancaster
Ivy Altomare, Yichen Lu, Sumanta Pal, Leigh Boehmer, Latha Shivakumar, Lyndsey Griffin, Kimberly Demirhan, Molly Kisiel, Randall Oyer
Abstract #: e13506

Treatment inequities in patients with metastatic non-small cell lung cancer harboring actionable driver oncogenes in the first-line setting
Partners: Flatiron Health, Foundation Medicine, Genentech, Mary Bird Perkins Cancer Center, New York Cancer and Blood Specialists, OneOncology, Tennessee Oncology, and West Cancer Center and Research Institute
Gregory Vidal, Thomas Stricker, Esprit Ma, Elaine Yu, Zhiyu Xia, Daniel Sheinson, Murat Sincan, Richard Huang, Victor Lin, Richard Zuniga, Neha Jain, Richard Martin, Davey Daniel
Abstract #: e13673

On May 23, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 10 abstracts highlighting the breadth and depth of the company’s screening and diagnostic portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, Ill (Press release, Exact Sciences, MAY 23, 2024, View Source [SID1234643648]). Presentations will include new data confirming both the predictive and prognostic value of the Oncotype DX Breast Recurrence Score test in racially and ethnically diverse patients. Exact Sciences will also present data on its approach to multi-cancer early detection (MCED) across multiple tumor types, plus additional real-world evidence showing optimized screening adherence strategies for the Cologuard test as well as high adherence rates for repeat screenings.

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"Exact Sciences’ growing evidence shows that earlier and more personalized treatment interventions lead to greater success for people living with cancer. Therefore, effective cancer screening and diagnostic tools are critical to improving patient outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. "These data presented at ASCO (Free ASCO Whitepaper) support our goal to set new screening and diagnostic standards through rigorous innovation and real-world data collection across cancer care. We are committed to continuing to develop high-quality tests that meet the needs of all patients, regardless of race, age, or ethnicity."

Precision Oncology

New data from two studies evaluating Recurrence Score results showed that the Oncotype DX Breast Recurrence Score test predicted breast cancer survival across different racial and ethnic groups. The first study confirmed that the test is prognostic for breast cancer-specific mortality and predictive of chemotherapy benefit across racial and ethnic groups in lymph node-negative patients, following propensity score-adjusted analyses. This real-world study of more than 171,000 patients with nonmetastatic, hormone receptor-positive, HER2-negative breast cancer with a Recurrence Score result from the SEER database also showed that the Recurrence Score result was predictive of chemotherapy benefit across all node-positive patients. In the study, non-Hispanic Black patients were shown to have a higher Recurrence Score result and chemotherapy usage compared to other groups. Exploratory analyses of the RxPONDER trial showed that while the test remained prognostic across racial and ethnic groups, non-Hispanic Black patients had higher proliferation axis scores, suggesting that differences in tumor biology may help explain differences in breast cancer outcomes.

Screening

New data suggests benefits of multi-cancer early detection (MCED) in identifying cancers earlier, with patients having a shorter time to diagnosis and fewer late-stage (Stage IV) diagnoses. In a modeling analysis, when MCED was evaluated across 12 different cancer types, it resulted in fewer Stage IV diagnoses relative to diagnosis through usual care, with 38% of Stage IV reductions attributed to cancers without recommended screening guidelines.

Exact Sciences will also share real-world evidence showing high adherence and three-year repeat rate of the Cologuard test. It will also share data demonstrating success with using different digital outreach approaches to help improve screening adherence, leading to high screening completion rates for the Cologuard test across different patient populations.

Data presentations across Exact Sciences’ Precision Oncology and Screening portfolio at ASCO (Free ASCO Whitepaper) 2024:

Precision Oncology

Abstract 515: Recurrence Score Gene Axes Scores by Race and Ethnicity in the RxPONDER Trial
Presenter: Y. Abdou, MD
Session: Rapid Oral Abstract Session
Date/time: Friday, May 31, 3:39 PM – 3:45 PM CDT
Key findings: This study analyzed Recurrence Score gene axis scores and their associations with outcomes to understand the differences in underlying tumor biology among different racial and ethnic groups. Recurrence Score gene axis scores differed by race/ethnicity, with Non-Hispanic Black patients exhibiting higher proliferation axis scores than other groups. This could partially explain the poorer outcomes observed in this population in the RxPONDER trial. These findings highlight the importance of tumor biology and support further investigation into the intricate factors contributing to disparities in outcomes to address them effectively.

Abstract 533/Poster Bd 125: Updated SEER database study of 21-gene assay to assess breast cancer-specific mortality and benefit of chemotherapy by race and ethnicity
Presenter: E. Diego, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Real-world evidence from the SEER registries in over 145,000 patients with breast cancer confirms that the Oncotype DX Breast Recurrence Score test is prognostic of breast cancer-specific survival across all racial and ethnic groups and predictive of chemotherapy benefit across most groups. This study was performed to further understand the racial and ethnic disparities identified in the TAILORx and RxPONDER phase 3 trials, which used the Oncotype DX test to identify patients with node-negative or node-positive breast cancer who may or may not benefit from chemotherapy. This latest SEER analysis provides further confidence in the prognostic value of the Oncotype DX test regardless of race or ethnicity.

Abstract 508: Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-) node-positive breast cancer
Presenter: L. Pusztai, MD, PhD, FASCO
Session: Oral Abstract Session
Date/time: Monday, June 3, 5:24 PM – 5:35 PM CDT
Location: Hall B1
Key findings: The RSClin N+ tool model delivers improved estimates of prognostic risk and absolute chemoendocrine therapy benefit over clinical or genomic data alone for patients with node-positive, HR+/HER2- breast cancer and could be used in patient counseling. Building upon the success of the RSClin tool, the N+ version of the RSClin tool integrates the Recurrence Score result with clinicopathologic factors, stratified by menopausal status, to further enhance its prognostic and predictive value for patients with node-positive disease.

Abstract 576/Poster Bd 168: Evaluating Ki67 and Oncotype DX Recurrence Score during neoadjuvant treatment with letrozole/abemaciclib or chemotherapy in highly proliferative HR+/HER2- breast cancer patients participating in the GEICAM CARABELA trial.
Presenter: A. Guerrero, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Highly proliferative breast cancer tumors (Ki67 ≥40%) or those with high Recurrence Score results (>25) showed lower residual cancer burden after neoadjuvant chemotherapy treatment versus neoadjuvant letrozole plus abemaciclib. These data confirm the predictive value of Ki67 and Recurrence Score risk assessments and suggest that relying solely on letrozole/abemaciclib as a systemic treatment for these tumors may be insufficient. This is an exploratory analysis from the CARABELA phase 2 trial, which is comparing the efficacy of neoadjuvant chemotherapy vs. neoadjuvant letrozole/abemaciclib treatment in patients with HR+/HER2- breast cancer who are at high/intermediate risk (stage II-III, Ki67≥20%).

Abstract 565: Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the Recurrence Score in node-positive breast cancer: independent validation in the PACS-01 trial
Presenter: F.M. Penault-Llorca, MD, PhD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Combining the Oncotype DX Breast Recurrence Score test with the Sensitivity to Endocrine Therapy (SET2,3) index, a biomarker-based assessment designed to assess a tumor’s response to hormonal therapy, successfully enhanced the prognostic value for patients with node-positive breast cancer. These are data from an independent, blinded validation analysis of the PACS-01 trial, which evaluated sequential adjuvant epirubicin-based and docetaxel chemotherapy for patients with node-positive breast cancer.

Abstract 10584/Poster Bd 111: Clinical and economic benefit of genomic testing strategies to guide the treatment of patients with HR+/HER2- breast cancer in the US
Presenter: B. Heald, MS
Session: Poster Session
Date/time: Monday, June 3, 1:30 PM CDT
Location: Hall A
Key findings: Using a testing strategy that combines both the Oncotype DX Breast Recurrence Score test and germline genetic testing (GGT), which identifies potentially pathogenic cancer variants, can help optimize treatment decisions in early HR+/HER2- breast cancer and improve patient outcomes at reduced costs, according to this health economic modeling study.

Screening

Abstract 11135/Poster Bd 330: Time-to-diagnosis and peri-diagnostic healthcare utilization between screen- and non-screen detected cancers: Evidence from SEER-Medicare
Presenter: X. Cao, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: Effective cancer screening programs successfully shortened the time to diagnosis and reduced the frequency of stage 4 diagnoses for patients with breast or colorectal cancer detected through screening. This retrospective SEER registry analysis reinforces that effective cancer screening technologies have the potential to improve patient outcomes by enabling earlier detection when treatment options are typically most successful.

Abstract 11076/ Poster Bd 271: Effect of multi-cancer early detection testing on late-stage cancers: A modeling study
Presenter: J. Chhatwal, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: In a 50-year modeling simulation, MCED testing resulted in 1,323 fewer Stage IV (24%) cancer diagnoses overall compared to usual care. Thirty-eight percent of these Stage IV reductions were attributable to screening for cancers without recommended guidelines, underscoring the potential of novel MCED strategies to help catch cancers earlier and initiate treatment interventions sooner.

Abstract e15632: Real-world multi-target stool DNA adherence in an underserved and vulnerable prison patient population.
Presenter: J. Kasselman
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: Among incarcerated persons, mt-sDNA yielded high adherence rates (95.3%) and short completion times (average of 20 days) in this difficult-to-reach population. These data further demonstrate the importance of efforts to uncover patient, provider, and system-level benefits that may be obtained through broader adoption of this highly accessible screening approach in this challenging healthcare setting.

Abstract e15633: Real-world multi-target stool DNA longitudinal adherence for colorectal cancer re-screening in a large, national population
Presenter: M. Greene
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: In a real-world longitudinal analysis of 481,748 patients, adherence to repeat colorectal cancer (CRC) screening with the Cologuard test remained high (83.6%), and patients who underwent repeat screening once were more likely to continue with a third lifetime Cologuard screening. These data suggest high perceived patient confidence in Cologuard, further reinforcing its potential to help close the CRC screening gap for average-risk individuals.

On May 23, 2024 Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, reported that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) ("LAE201")in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment (Press release, Laekna Therapeutics, MAY 23, 2024, https://www.prnewswire.com/news-releases/laekna-announces-fda-approval-for-the-phase-iii-clinical-trial-protocol-of-lae002-afuresertib-plus-lae001-for-the-treatment-of-prostate-cancer-302154036.html [SID1234643647]).

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Laekna initiated a Phase II clinical trial of the multi-region clinical trial of the study of LAE201 in the U.S. in June 2021, and South Korea in September 2022. The trial is an open-label, dose-escalation and dose expansion study to assess the efficacy and safety of the combination candidate.

The study demonstrated promising treatment benefit for mCRPC patients. As of Nov 21, 2023, 40 patients who progressed on 1–3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation of AR antagonists, had been enrolled in the recommended phase II dose group. The median rPFS was 8.1 months. This is a significant improvement compared to the median rPFS of 2 to 4 months of mCRPC patients under the standard treatments historically[1]. The combination therapy was generally tolerable with manageable treatment emergent adverse events and recoverable after routine treatments.

"Since the Phase II data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following Phase III pivotal trial design has been discussed with the U.S. FDA and the approval for the protocol has been received this month," said Dr. Yong Yue, Chief Medical Officer of Laekna. "The approval marks a significant milestone for Laekna. The mCRPC post 1-3 lines of SOC are difficult-to-treat late stage cancer with poor outcomes. It is an unmet medical need worldwide.We look forward to bringing this precision therapy to mCRPC patients who are in need of novel treatment options."

[1] R. de Wit, et al., 2019;Rhian Sian Davies et al., 2016

About afuresertib

Afuresertib(LAE002) is one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally.

Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). Afuresertib has demonstrated several advantages compared to other AKT inhibitors, including higher efficacy, better potency, more significant tumor inhibition exposure and a better safety profile, based on public data. Capivasertib is the first approved AKT inhibitor from AstraZeneca, which FDA approved for HR+/HER2- breast cancer in November 2023.

With the promising efficacy data from our afuresertib Phase Ib study for HR+/HER2- breast cancer, which was presented in SABCS 2023, Laekna has initiated the Phase III pivotal study. We also continue to develop our clinical trials for the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/PD-L1 drug-resistant solid tumors to address the unmet medical needs. In several clinical trials, the combination of afuresertib with other therapeutics exhibits favorable efficacy results.

About LAE001

LAE001 is an androgen synthesis inhibitor that inhibits both CYP17A1 and CYP11B2. Laekna in-licensed LAE001 from Novartis in 2017. According to Frost & Sullivan, LAE001 is the only dual CYP17A1/CYP11B2 inhibitor in clinical trials for the treatment of prostate cancer globally.

As a dual CYP17A1/CYP11B2 inhibitor, LAE001 can block both androgen and aldosterone synthesis and potentially be administrated without prednisone, the short-term high dose or long-term exposure of which can lead to a variety of adverse events.

On May 23, 2024 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that Medivir’s licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has announced that the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts (Press release, Medivir, MAY 23, 2024, View Source [SID1234643646]).

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TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor, for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers, and has been developed by Tango from the preclinical USP1 program licensed from Medivir in 2020. At present, Medivir has no additional information than what has been announced in Tango’s press release: View Source

The announcement by Tango Therapeutics has no impact on Medivir’s focus and development efforts with its lead program fostroxacitabine bralpamide (fostrox) for the treatment of primary liver cancer (HCC). Medivir continues to maximize the momentum of the fostrox development program as it accelerates a number of critical activities to enable initiation of a pivotal phase 2b study with accelerated approval intent. If successful outcome of the planned study, fostrox has the potential to become the first approved treatment for HCC patients who have progressed on current first-line standard of care, a market valued at ~$2.5bn annually by 2028.