On May 25, 2023 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported encouraging results from the Phase 1b/2 study (ClinialTrial.gov Identifier: NCT04322006) evaluating uliledlimab, the Company’s proprietary and highly differentiated CD73 antibody, in combination with toripalimab (TUOYI), a PD-1 antibody, in patients with treatment-naïve advanced non-small cell lung cancer (NSCLC), and exploring the potential value of CD73 expression as a predictive biomarker (Press release, I-Mab Biopharma, MAY 25, 2023, View Source [SID1234632105]). The results will be reported in a poster presentation on June 3 at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The study is a dose expansion portion of a Phase 1b/2 trial evaluating the safety and efficacy of the combination therapy and investigating the potential correlation between tumor CD73 expression and clinical response for patients with treatment-naïve advanced NSCLC.

As of April 14, 2023, a total of 70 patients were enrolled in the study. Uliledlimab demonstrated a favorable safety profile up to 30mg/kg Q3W in combination with toripalimab with most treatment-related adverse events (TRAEs) being Grade 1 or Grade 2 in severity. In the efficacy evaluable population (n=67), the objective response rate (ORR) was 31.3% regardless of PD-L1 and CD73 expression. CD73High was established as >40% of tumor or immune cells with ≥1+ staining intensity identified by immunohistochemistry (IHC). The cutoff was determined through receiver operating characteristic (ROC) analysis.

Notably, patients with CD73High exhibited a higher ORR compared with those with CD73Low (53% vs. 18%). The ORR further increased to 63% in patients with both CD73High and PD-L1 tumor proportion score (TPS)≥1%, whereas patients with CD73Low had an ORR of 20%. At the time of data cutoff, with a median follow-up of 10.4 months, 18 out of 21 responders remained on treatment, and the median duration of response (DOR) was not reached. Progression-free survival (PFS) and overall survival (OS) data will be analyzed when the data are fully mature.

"These results hold promise for the treatment of NSCLC patients, as demonstrated by the favorable safety and efficacy outcomes," said Professor Yi-Long Wu, Principal Investigator of the study and Professor of Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences and Guangdong Lung Cancer Institute. "We are particularly excited about the potential of CD73 expression as a predictive biomarker, which is consistent with findings in our previous studies. The results may transform how we personalize NSCLC treatment through stratification by a predictive biomarker."

"The new results are compelling for uliledlimab as a new treatment for NSCLC and its potential to make a meaningful impact on patients’ lives. We’re particularly excited by the strong correlation between high CD73 expression and clinical response. With this finding, we are in a unique position to apply CD73 as a predictive biomarker to raise the probability of treatment success for NSCLC," said Dr. Andrew Zhu, President and Acting CEO of I-Mab. "Building on encouraging results from this study, we intend to commence a biomarker-guided pivotal trial with the aim of providing these promising new treatment options to patients as quickly as we can."

These data will be reported in a poster presentation, entitled Uliledlimab and Toripalimab Combination Therapy in Treatment Naïve Advanced NSCLC: Phase 1b/2 Clinical Trial Results Using CD73 as a Potential Predictive Biomarker (Abstract #2570), at ASCO (Free ASCO Whitepaper) on June 3, 2023, from 8:00 a.m. – 11:00 a.m. C.T. by Dr. Qing Zhou, Professor of Guangdong Provincial People’s Hospital.

About Uliledlimab

Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical studies.

On May 25, 2023 Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, reported two poster presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 2–6, 2023, in Chicago, Illinois and online (Press release, BioTheryX, MAY 25, 2023, View Source [SID1234632104]). The presentations highlight preclinical data for bifunctional degraders of CDK4/6, including development candidate BTX-9341, for the treatment of estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-), and of son of sevenless homolog 1 (SOS1) for the treatment of KRAS mutant cancers.

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"These new preclinical data demonstrate the potential of our bifunctional CDK4/6 and SOS1 degraders to potently degrade their targets, ultimately effectively inhibiting tumor growth together with the strength of Biotheryx’s PRODEGY platform to efficiently design first-in-class degraders," said Philippe Drouet, President and Chief Executive Officer of Biotheryx. "Besides these encouraging efficacy results, BTX-9341, our oral CDK4/6 development candidate, exhibited superior blood brain barrier penetration versus inhibitors and good tumor exposure when dosed orally. We look forward to advancing BTX-9341 towards clinical development to overcome drug resistance challenges faced by patients with solid tumors such as ER+/HER2- breast cancer."

2023 ASCO (Free ASCO Whitepaper) Annual Meeting Presentation Details:

Title: Discovery of CDK4/6 bifunctional degraders for ER+/HER2- breast cancer and triple negative breast cancer
Presenter: Hannah Majeski, Ph.D., Principal Scientist – Biology
Abstract #: 1083
Session: Breast Cancer – Metastatic
Session Date and Time: Sunday, June 4, 2023, at 8:00 a.m. CDT
Highlights:

CDK4/6 inhibitors are used to treat ER+/ HER2- breast cancer, but some patients have exhibited innate resistance, and many are shown to develop acquired resistance after three years on therapy.
BTX-9341, discovered and developed by Biotheryx’s proprietary PRODEGY platform, is a potent, Cereblon- and proteasome-dependent degrader of CDK4 and CDK6 in multiple breast cancer cell lines.
BTX-9341 demonstrated in vitro CDK4 and CDK6 degradation in multiple breast cancer cell lines and potent inhibition of cell proliferation. This potency was shown to be superior to CDK4/6 inhibitors, due to Cereblon-mediated target degradation.
The CDK4/6 bifunctional degraders were active in a CDK4/6 inhibitor resistant cell line and in multiple PDX CDK4/6 inhibitor resistant organoid models.
BTX-9341 exhibited good tumor exposure when dosed orally, and induced a dose-dependent reduction in CDK4, CDK6 and pRB levels in MCF7 xenograft tumors. This resulted in dose dependent tumor growth inhibition, tumor regression and superior efficacy compared to CDK4/6 inhibitors.
BTX-9341 and its analogue bifunctional degraders have also shown blood brain barrier penetration and superior inhibition of tumor growth in an MCF7 intracranial mouse model compared to a CDK4/6 inhibitor.
The combination of the enhanced efficacy, activity in CDK4/6 inhibitor resistant models and blood brain barrier penetration demonstrate the potential for CDK4/6 degraders in a range of potential cancer indications.
Title: Development of bifunctional CRBN-SOS1 degraders for treatment of mutant KRAS cancers
Presenter: Kyle Begovich, Ph.D., Senior Scientist – Biology
Abstract #: 3151
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Saturday, June 3, 2023, at 8:00 a.m. CDT
Highlights:

KRAS is the most frequently mutated cancer-causing oncogene and is mutated in over 20% of all human cancers, including an estimated 90% of pancreatic cancer, 45% of colorectal cancer and 30% of lung cancer. Combination therapeutic approaches are likely needed to avoid drug resistance in the treatment of KRAS mutant cancers, such as coupling KRAS inhibition with a blockade of its guanine exchange factor (GEF), SOS1, to keep KRAS in its inactive state as well as prevent upstream pathway reactivation.
Biotheryx’s SOS1 bifunctional degraders demonstrated antiproliferative effects across a range of KRAS-mutant cell lines. Treatment with SOS1 degraders in KRAS-mutant xenograft models resulted in greater than 90% degradation of SOS1 in tumors and subsequently led to significant tumor growth inhibition as a single agent.
SOS1 degraders also exhibited synergistic effects with other RAS/MAPK pathway inhibitors, such as KRAS G12C, KRASG12D, EGFR and MEK inhibitors in in vitro studies as well as in KRAS-mutant xenograft models.
These data support the potential of SOS1 degradation as a valuable treatment option for a range of KRAS mutant cancers, as a monotherapy and in combination with other RAS-MAPK pathway inhibitors.
Following the presentations at the meeting, PDF copies of the presentations and posters will be available in the "Publications and Presentations" section of Biotheryx’s website.

On May 25, 2023 Rutgers Cancer Institute of New Jersey and RWJBarnabas Health reported that data from SWOG S1826, a randomized study of nivolumab(N)-AVD versus brentuximab vedotin(BV)-AVD in advanced stage (AS) classic Hodgkin lymphoma (HL), and two abstracts from the neoadjuvant I-SPY 2 trial evaluating oral paclitaxel, carboplatin, and dostarlimab (OPE/Cb/D) without and with trastuzumab in early-stage, high-risk breast cancer, have been selected as late-breaking presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held both in person in Chicago and online from June 2-6 (Press release, Rutgers Cancer Institute of New Jersey, MAY 25, 2023, View Source [SID1234632103]).

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"We are thrilled to have physician-scientists from our health system participate in two innovative clinical trials selected for three late-breaking presentations at this year’s ASCO (Free ASCO Whitepaper) annual meeting, reinforcing our commitment to push the boundaries of science, provide patients with cutting-edge treatment options, and transform the way cancer is treated," said Steven K. Libutti, MD, FACS, Director, Rutgers Cancer Institute of New Jersey and Senior Vice President, Oncology Services, RWJBarnabas Health. "As New Jersey’s only NCI-Designated Comprehensive Cancer Center, we strive to offer our patients comprehensive cancer care, including access to novel therapeutic advances and game-changing clinical trials that have the potential to save, extend and improve the quality of patients’ lives, and reshape the future of cancer management."

A total of 33 presentations and 9 publications have been accepted, highlighting research advances in several types of cancer, including lymphoma, pediatric, colorectal and breast cancer.

Highlights of additional accepted abstracts include the following:

Initial findings of the phase II study of biweekly TAS-102, irinotecan and bevacizumab in pre-treated metastatic colorectal cancer (mCRC), found that TAS-102 with irinotecan plus bevacizumab is an effective second-line therapy for patients with mCRC.
Findings from a cross-sectional, retrospective analysis that aimed to determine the association of receipt of treatment summaries, follow-up care instructions (including where to obtain "routine cancer check-ups"), and type of doctor providing survivorship care on breast cancer screening (BCS) and cervical cancer screening (CCS) in female cancer survivors. The analysis demonstrated that follow-up instructions, which are part of the survivorship plan, have the greatest association with BCS and CCS among cancer survivors, but despite this, about 25% of BCS and CCS-eligible cancer survivors did not receive them.
Results from a phase Ib/II clinical trial evaluating the preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors, which demonstrated that tinengotinib monotherapy was well-tolerated and the pharmacokinetics results may support dose recommendation for subsequent trials. Additionally, researchers observed encouraging anticancer activity of tinengotinib monotherapy in patients with heavily pre-treated solid tumors, including PC, HR+/HER2- BC, TNBC and CCA.
The full list of presentations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting follows:

Oral Presentations

Abstract No.

Title

Presentation
Date/Time

Location

Abstract 8006

LINKER-MM1 study:
Linvoseltamab (REGN5458) in
patients with relapsed/refractory
multiple myeloma.

Saturday, June 3, 2023,
3:15 p.m. CDT

Hall D2 & Live Stream

Abstract 9501

Significant durable response with
fianlimab (anti-LAG-3) and
cemiplimab (anti-PD-1) in advanced
melanoma: Post adjuvant PD-1
analysis.

Monday, June 5, 2023,

3:00 p.m. CDT

Hall D1 & Live Stream

Abstract 1004

A phase 2 study of HER3-DXd in
patients (pts) with metastatic breast
cancer (MBC).

Monday, June 5, 2023,

12:42 p.m. CDT

Hall B1 & Live Stream

Abstract 10008

Phase 2 study of larotrectinib in
children with newly diagnosed
infantile fibrosarcoma (IFS):
Children’s Oncology Group (COG)
ADVL1823 cohort A.

Sunday, June 4, 2023,

12:09 p.m. CDT

S100a & Live Stream

Poster Presentations

Abstract No.

Title

Presentation
Date/Time

Location

Abstract
LBA612

Oral paclitaxel and dostarlimab with
or without trastuzumab in early-
stage, high-risk breast cancer:
Results from the neoadjuvant I SPY
2 TRIAL.

Sunday, June 4, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract
TPS3625

Phase II/III study of circulating
tumor DNA as a predictive
biomarker in adjuvant chemotherapy
in patients with stage II colon
cancer: NRG-GI005 (COBRA).

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract
TPS5103

SWOG S1823/CCTG GCC1:
Translational observational
investigational study of the liquid
biomarker microRNA 371a-3p in
newly diagnosed germ cell
tumours—Real-world trial design,
rapid accrual, and robust secondary
use of data opportunities.

Saturday, June 3, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract
TPS5109

HB-300, a novel arenavirus-based
cancer immunotherapy in patients
with metastatic castration-resistant
prostate cancer.

Saturday, June 3, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract
TPS5110

A phase 1/2 study of combination
olaparib and radium-223 in men
with metastatic castration-resistant
prostate cancer with bone metastases
(COMRADE): A trial in progress.

Saturday, June 3, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract
TPS9594

A phase 2/3 trial in progress on
tebentafusp as monotherapy and in
combination with pembrolizumab in
HLA-A*02:01+ patients with
previously treated advanced non-
uveal melanoma (TEBE-AM).

Saturday, June 3, 2023,

1:15 – 4:15 p.m. CDT

Hall A & On Demand

Abstract 532

A multicenter phase II study of
vaccines to prevent recurrence in
patients with HER-2–positive breast
cancer.

Sunday, June 4, 2023,

8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 2561

Clinical outcomes of immune
checkpoint inhibitor treatment in
patients with classic cold tumors
identified to have a high tumor
mutational burden via ctDNA.

Saturday, June 3, 2023,

8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 3085

Characterization of MCL-1 in
patients with colorectal cancer
(CRC): Expression, molecular
profiles, and outcomes.

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 3531

Chemotherapeutic sensitivity in
colorectal cancer expressing low
RNA of wild type homologous
recombination genes.

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 3590

Phase II study of biweekly TAS-
102, irinotecan and bevacizumab in
pre-treated metastatic colorectal
cancer (TABAsCO).

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 3622

Molecular profiling and
characterization of the tumor
immune microenvironment (TME)
in appendiceal carcinoma (AC).

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4108

Comprehensive profiling of clock
genes expression in hepatocellular
carcinoma (HCC).

Monday, June 5, 2023,

8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4144

Correlation of comprehensive
molecular mapping of pancreatic
ductal adenocarcinoma with XPO1
mRNA expression levels to potential
clinical targets.

Monday, June 5, 2023,

8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4145

Clinical genomic implications of
transcriptional subtypes in
pancreatic cancer.

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4150

KRAS G12C-mutated pancreatic
cancer: Clinical outcomes based on
chemotherapeutic regimen.

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4151

Molecular and clinical correlates of
DSCR1 expression in pancreatic
cancer (PDAC).

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 4167

The five periampullary cancers: Not
just different siblings but different
families—An international
multicenter cohort study.

Monday, June 5, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 9548

A phase 1 study of fianlimab (anti-
LAG-3) in combination with
cemiplimab (anti-PD-1) in patients
with advanced melanoma: Poor-
prognosis subgroup analysis.

Saturday, June 3, 2023,

1:15 – 4:15 p.m. CDT

Hall A & On Demand

Abstract 10628

Learned lessons from a US-wide
outreach program to broaden
enrollment to the PROMISE
Registry, a prostate cancer genetic
registry.

Saturday, June 3, 2023,
1:15 – 4:15 p.m. CDT

Hall A & On Demand

Abstract 11018

Characterizing imposter syndrome
among oncologists on social media.

Sunday, June 4, 2023,
8:00 – 11:00 a.m. CDT

Hall A & On Demand

Abstract 12075

Survivorship care and breast and
cervical cancer screening.

Monday, June 5, 2023,

1:15 – 4:15 p.m. CDT

Hall A & On Demand

Poster Discussion Session

Abstract 2519

A phase I/II trial investigating safety
and efficacy of autologous TAC01-
HER2 in relapsed or refractory solid
tumors.

Saturday, June 3, 2023,
3:00 – 4:30 p.m. CDT

S100bc & On Demand

Abstract 3019

Preliminary safety and efficacy of
tinengotinib tablets as monotherapy
and combination therapy in
advanced solid tumors: A phase Ib/II
clinical trial.

Saturday, June 3, 2023,

2:11 p.m. CDT

S100bc & On Demand

Abstract 4020

Not all treated KRAS-mutant
pancreatic adenocarcinomas are
equal: KRAS G12D and survival
outcome.

Monday, June 5, 2023,

11:30 – 1:00 p.m. CDT

Hall D2 & Live Stream

Abstract 7515

Response-adapted therapy (tx) with
nivolumab plus brentuximab vedotin
(nivo + BV) without autologous
hematopoietic cell transplantation
(auto-HCT) in children, adolescents,
and young adults (CAYA) with low-
risk relapsed/refractory (R/R) classic
Hodgkin lymphoma (cHL):
CheckMate 744.

Monday, June 5, 2023,

1:49 p.m. CDT

E450 & On Demand

Abstract Discussion 4

Aging in Survivors of Pediatric
Cancer

Monday, June 5, 2023,
5:36 p.m. CDT

S504 & On Demand

Abstract LBA520

Oral paclitaxel, carboplatin, and
dostarlimab (OPE/Cb/D) without
and with trastuzumab in early-stage,
high-risk breast cancer: Results from
the neoadjuvant I-SPY 2 TRIAL.

Sunday, June 4, 2023,

5:04 p.m. CDT

Hall B1 & Live Stream

Plenary Session

Abstract LBA4

SWOG S1826, a randomized study
of nivolumab(N)-AVD versus
brentuximab vedotin (BV)-AVD in
advanced stage (AS) classic
Hodgkin lymphoma (HL).

Sunday, June 4, 2023,

2:53 p.m. CDT

Hall B1 & Live Stream

Publication Only

Session title

Presentation title

Presentation
Date/Time

Location

Abstract e16073

Preoperative pembrolizumab for
MSI high, EBV positive or PD-L1
positive locally advanced gastric
cancer followed by surgery and
adjuvant chemoradiation with
pembrolizumab: Interim results of a
phase 2 multi-center trial.

N/A

N/A

Abstract e18723

Assessment of how differences in
efficacy and toxicity change
healthcare professionals’ views on
presentation of treatment options.

N/A

N/A

Abstract e15087

Safety and feasibility of the addition
of a radiosensitizing methionine-
restricted diet to radiation therapy.

N/A

N/A

Abstract e17618

Comparing sentinel
lymphadenectomy and complete
lymphadenectomy among obese
patients (BMI >30) undergoing
minimally invasive hysterectomy for
early-stage endometrial cancer: An
ACS-NSQIP database study.

N/A

N/A

Abstract e18605

Immediate inpatient toxicities
associated with CAR T-cell therapy:
Real world data from a national
inpatient sample.

N/A

N/A

Abstract e24088

Barriers to offering female fertility
preservation to pediatric and young
adult oncology patients: A national
survey of pediatric hematology
oncology providers in the United
States and Canada.

N/A

N/A

Abstract e12523

ctDNA detection before and during
systemic therapy for inflammatory
breast cancer.

N/A

N/A

Abstract e16079

Outcomes of Helicobacter pylori
(HP) infection in esophageal cancer
(EC): A 5-year nationwide analysis.

N/A

N/A

Abstract e19015

Pevonedistat plus belinostat in
relapsed/refractory acute myeloid
leukemia or myelodysplastic
syndrome: A phase I multicenter
study.

N/A

N/A

On May 25, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported poster presentations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023, in Chicago, IL (Press release, Aadi Bioscience, MAY 25, 2023, View Source [SID1234632102]). The abstracts associated with the poster presentations are now available on the ASCO (Free ASCO Whitepaper) meeting website.

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Details of the poster presentations are below:

Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I)"
Date and Time: June 3, 2023, 8:00 AM-11:00 AM CT
Session Type/Title: Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Gopa Iyer, MD, Memorial Sloan Kettering Cancer Center
Abstract Number: TPS3168

A trial-in-progress poster detailing the PRECISION I trial will be presented. This study aims to determine the efficacy and safety profile of nab-sirolimus in patients with malignant solid tumors with pathogenic inactivating alterations in TSC1 (Arm A) or TSC2 (Arm B).
Available data from the AMPECT exploratory analysis and an expanded access program suggest acceptable efficacy and safety of nab-sirolimus, an mTORi with enhanced antitumor activity, in patients with solid tumors harboring inactivating alterations in TSC1 and/or TSC2.
Collaboration with leading next generation sequencing vendors will expedite the identification of patients with qualifying TSC1 or TSC2 alterations; study access will be facilitated through a "just in time" approach to trial location activation.
Title: "A phase I study of nanoparticle albumin-bound sirolimus (NAB-S) combined with pazopanib (PAZO) in patients with advanced soft tissue sarcoma (STS)"
Poster Session Display Date and Time: June 3, 2023, 1:15 PM-4:15 PM CT
Poster Board Number: 455
Poster Discussion Session Date and Time: June 3, 2023, 4:30 PM-6:00 PM CT
Session Category: Clinical Research Excluding Trials
Session Title: Poster Discussion Session – Sarcoma
Presenter: Lee Cranmer, MD, PhD, FACP, Fred Hutch Cancer Center
Abstract Number: 11521

Data from an ongoing Phase 1 investigator-initiated trial evaluating the combination of nab-sirolimus and pazopanib in patients with soft tissue sarcoma will be presented.
The maximum tolerated dose and recommended Phase 2 dose is nab-sirolimus 30 mg/m2 day 1 and pazopanib 400 mg days 1-21.
No new safety signals were identified with this combination; the most commonly reported adverse events included thrombocytopenia, mucositis, fatigue, and acneiform rash.
Preliminary evidence of activity of the combination was observed, with 3 of the 18 evaluable patients having achieved a partial response, and 13 achieving stable disease.
Following the presentations at ASCO (Free ASCO Whitepaper), the posters will be made available on the investor relations page of the Aadi website at www.aadibio.com.

On May 25, 2023 OneOncology’s clinical team reported that it will present Oral Abstracts using real-world data to evidence better health outcomes when advanced Non-Small Cell Lung Cancer (aNCSLC) patients receive biomarker testing, including Next-Generation Sequencing (NGS) testing, to determine whether the patient has an actionable driver oncogene for a targeted therapy, even if a non-targeted therapy has begun, as well as the current inequities in receiving NGS testing between White, Black, and Latinx populations at the 2023 ASCO (Free ASCO Whitepaper) annual meeting (Press release, OneOncology, MAY 25, 2023, View Source [SID1234632100]).

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OneOncology Presents Abstracts at ASCO (Free ASCO Whitepaper) Highlighting Importance of Increasing NGS Testing

OneOncology’s Clinical Team Showcases NGS and Biomarket Testing Absracts At ASCO (Free ASCO Whitepaper) 2023
OneOncology’s Clinical Team Showcases NGS and Biomarket Testing Absracts At ASCO (Free ASCO Whitepaper) 2023
Thomas Stricker, MD, Ph.D., Medical Director of Precision Medicine for OneOncology, is the first author of Abstract 6507, Clinical Value of Timely Treatment for Advanced Non-Small Cell Lung Cancer Patients (aNSCLC) with Actionable Driver Oncogenes, which observed better health outcomes for aNSCLC patients who began therapy with a targeted treatment compared with non-targeted treatment. The research also showed comparable outcomes to Upfront targeted treatment for aNSCLC patients who switched to targeted therapy within 42 days after biomarker testing result was available, even if the patient had already begun a non-targeted treatment, such as chemotherapy.

"Our research shows that oncologists should use, and act upon biomarker information, as soon as possible – even if it is after a non-targeted treatment has begun," said Dr. Stricker. "While it’s crucial we improve utilization of NGS testing to identify all actionable driver oncogenes upfront, so that we can deliver the right therapy to the right patient at the right time, this work shows that even if the initial result is delayed and the patient is started on a non-targeted therapy, switching to the targeted therapy that is suggested by the NGS results has benefit for the patient."

Dr. Stricker’s research examined the Flatiron Health de-identified electronic health record data of 5,156 NSCLC patients with an actionable cancer gene. Seventy-nine percent were treated in the community setting, and 56 percent received NGS testing.

In Abstract 6508, Practice-and Provider-Level Inequities in Next-Generation Sequencing Testing by Race/Ethnicity for Patients with aNSCLC in the Community Setting, first author, Gregory Vidal, M.D., Ph.D., Chair of Breast Cancer Disease Group, OneOncology, and Director of Clinical Research, West Cancer Center & Research Institute. His team found by examining Flatiron Health de-identified electronic health record data that inequities at the provider and practice levels were meaningful contributors to the inequitable utilization of NGS among Black, Latinx, and White patients with advanced Non-Small Cell Lung Cancer.

Dr. Vidal’s research has important implications, as healthcare delivery experts move "from characterizing inequities to designing, implementing, and evaluating interventions and policies aimed at improving equitable, timely NGS testing as a quality-of-care metric" in aNSCLC patients specifically, and all cancer patients, generally.

"Our findings show the racial/ethnic inequities in NGS testing were driven by within- and across-practice inequalities, as well as across-provider inequities, which could potentially reflect system barriers to access to care," Dr. Vidal said. "Our research points to the need for systematic program interventions and policies to improve timely access to NGS testing among Black and Latinx patients."

The study’s result of 12,045 patients diagnosed with aNSCLC (9,981 White, 1,528 Black, and 536 Latinx) showed that within and between practices inequities contributed to total inequity in NGS testing for Black patients (48 percent and 52 percent of total inequity mean percentage-point of 7.49), and Latinx patients (60 percent and 40 percent of total inequity mean percentage-point of 8.26) compared with White patients.

Dr. Vidal’s research builds upon earlier OneOncology research, that showed OneOncology had a higher NGS uptake with a shorter time to testing in metastatic breast cancer than non-OneOncology community cancer centers, possibly related to OneOncology’s network-wide strategy recommending NGS testing at diagnosis of advanced disease. These studies highlight the importance of built-in processes that recommend NGS testing and alert physicians when additional testing may be necessary—an effort that is actively being led by OneOncology’s Precision Medicine team.

Both studies were conducted with Genentech, a member of the Roche Group, as part of a multi-year strategic partnership to collaborate on various clinical trials, scientific research, and real-world data studies advancing personalized cancer care in community oncology centers. OneOncology partner practices that participated in Dr. Stricker’s study include Mary Bird Perkins, Eastern Connecticut Hematology & Oncology Associates, West Cancer Center and Research Institute, New York Cancer and Blood Specialists, Astera Cancer Care, Los Angeles Cancer Network, and Tennessee Oncology.

Drs. Stricker and Vidal will each present their Abstracts during the June 6 Health Services Research and Quality Improvement Abstract Oral Presentation Session from 8:00 AM – 11:00 AM.

To set up an interview at ASCO (Free ASCO Whitepaper), contact Eric Hoffman, [email protected].