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].

On May 25, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer (Press release, Oncolytics Biotech, MAY 25, 2023, View Source [SID1234632099]). The results are published in an abstract accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 2 – 6, 2023 in Chicago, Illinois and online. The abstract is available on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

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BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.

Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed ≥50% improvements on the trial’s primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO (Free ASCO Whitepaper) abstract cut-off date (October 2022). This cohort also reported median progression-free survival (mPFS) of 9.6 months vs. 6.4 months as of the cut-off date. Overall survival data from the trial continue to mature. Data from this study validate the results of IND-213, a prior phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29).

"BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone," said Dr. Matt Coffey, President and Chief Executive Officer. "Importantly, evidence of pelareorep’s ability to synergistically enhance paclitaxel’s efficacy has now been seen consistently across multiple clinical efficacy endpoints of overall survival, progression-free survival, and ORR. With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway. I would like to thank BRACELET-1’s participants as well as our collaborators at Pfizer, Merck KGaA, Darmstadt, Germany, and PrECOG, all of whom contributed to an important trial that will inform and accelerate pelareorep’s path to approval."

A detailed summary of BRACELET-1’s data are shown below. Updated results as of a May cut-off date will be featured in an oral presentation at the ASCO (Free ASCO Whitepaper) meeting on June 3, 2023.

Response and Progression-free Survival (October 2022 data cut-off):

Paclitaxel (PTX) Monotherapy (n=15)

PTX + Pelareorep (n=16)

PTX + Pelareorep + Avelumab (n=17)

ORR at Week 161

3 (20 %)

5 (31.3 %)

3 (17.6 %)

Disease Control Rate at Week 16 (CR+PR+SD)

7 (46.7 %)

10 (62.5 %)

12 (70.6 %)

mPFS (months)1

6.4

(95% CI: 2.0, NR)

9.6

(95% CI: 6.5, NR)

7.5

(95% CI: 3.8, NR)

6-month PFS Rate

62.5%

(95% CI: 27.6%, 84.2%)

92.9%

(95% CI: 59.1%, 99%)

73.2%

(95% CI: 42%, 89.4%)

1. Three patients who withdrew consent prior to starting therapy and two patints who discontinued treatment after week 1 were considered non-responders and censored for PFS

CI: Confidence interval; CR: Complete response; PR: Partial response; SD: Stable disease; NR: Not reached

Biomarker and Safety

A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab)
Pelareorep displayed an acceptable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients
Dr. Thomas Heineman, Chief Medical Officer, commented, "BRACELET-1 was a well-conducted study in a randomized setting that included a control arm that performed as expected and a test arm that provides significant evidence of pelareorep’s ability to provide additional meaningful clinical benefit in HR+/HER2- breast cancer patients. Mechanistic data from prior clinical trials indicate pelareorep’s anti-cancer effects are derived from its ability to reverse immunosuppressive tumor microenvironments and stimulate the expansion of anti-cancer T cells. These prior data align with BRACELET-1’s results that show an association between T cell expansion and efficacy."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "BRACELET-1’s data greatly enhance our pipeline’s value proposition, bringing our breast cancer program to pivotal trial-readiness and confirming pelareorep’s potential to address large markets by synergistically combining with other anti-cancer agents. Looking ahead, we believe our data in breast cancer, together with the second registration opportunity offered by our pancreatic cancer program, leave us well-positioned as we continue to execute our business development efforts. To ensure we maximize value for shareholders, we remain committed to taking a disciplined and methodical approach as we further discussions with our potential partners in the biopharma community."

Details on the upcoming ASCO (Free ASCO Whitepaper) oral presentation on BRACELET-1 are shown below.

Title: BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab

Abstract Number: 1012

Session Type: Clinical Science Symposium

Session Title: The Dr. Bernard Fisher Memorial Annual Clinical Science Symposium Supported by the Breast Cancer Research Foundation: Harnessing the Breast Cancer Immune Response

Session Date and Time: June 3, 2023 | 1:15 p.m. – 2:45 p.m. CT

A copy of slides from the ASCO (Free ASCO Whitepaper) presentation will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

About BRACELET-1

The BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Pfizer Inc. and Merck KGaA, Darmstadt, Germany. PrECOG LLC, a leading cancer research network, is managing the study. The study randomized 45 patients 1:1:1 into three cohorts. A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts are treated as follows:

Cohort 1: paclitaxel
Cohort 2: paclitaxel + pelareorep
Cohort 3: paclitaxel + pelareorep + avelumab (Bavencio)
Patients in cohort 1 receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate at week 16. Exploratory endpoints include progression-free survival, peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

On May 25, 2023 Dizal (688192.SH) reported that data from its oncology portfolio will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6, 2023 in Chicago (Press release, Dizal Pharma, MAY 25, 2023, View Source [SID1234632098]). The data which include updated analyses of Dizal’s two leading assets – sunvozertinib (a selective EGFR TKI targeting a wide spectrum of EGFR mutations) and golidocitinib (a highly selective JAK1 inhibitor), underscore Dizal’s dedication to developing and delivering innovative medicines that will make a meaningful difference to people living with cancer.

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Presentation Highlights

Sunvozertinib

Dizal will present updated results of WU-KONG6, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR Exon20ins mutations in an oral session.

Patients treated with sunvozertinib (n = 97) achieved a confirmed objective response rate (cORR) of 60.8% assessed by independent review committee (IRC). Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and tumor response was also observed in patients with pretreated and stable brain metastasis. Sunvozertinib showed significant anti-tumor efficacy and well tolerated safety profiles. These data suggest that sunvozertinib could be an effective and safe treatment option for this unmet medical need.

Golidocitinib

The clinical data of JACKPOT8 Part B, a multinational pivotal study of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) will make its debut at the meeting.

PTCL is a group of heterogenous and rare non-Hodgkin lymphoma originating from mature T cells. There is no consensus on the standard treatment for r/r PTCL. Golidocitinib demonstrated promising and durable anti-tumor efficacy, making it a superior treatment option to fight against this devastating disease. This data was also accepted as an encore presentation at the 17th International Conference on Malignant Lymphoma Lugano (ICML) and will be presented orally.

In addition, two abstracts about sunvozertinib in the first line setting and heavily pretreated EGFR mutant NSCLC, respectively, were selected as poster presentations in ASCO (Free ASCO Whitepaper) 2023 annual meeting, including:

The "best-in-class" potential of sunvozertinib as a first line treatment for NSCLC patients with EGFR Exon20ins mutations.
Promising anti-tumor efficacy of sunvozertinib with median PFS of close to 6 months in heavily pretreated NSCLC patients with EGFR sensitizing mutations who failed standard EGFR TKI treatment (median 5 lines of prior therapies).
The updated data will be presented at the meeting.

"We are thrilled to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) meeting, showcasing our strong portfolio and rapid acceleration of our pipeline in oncology and hematological malignancies." said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Sunvozertinib has further reinforced its best-in-class position with an even higher ORR, while golidocitinib will debut its global pivotal study results, demonstrating its superior efficacy. These presentations reflect the high quality of our science and our unwavering commitment to advance cancer research and improve patient outcomes."

Select studies, along with the dates, times and locations of their data sessions, are highlighted below.

Lead Author

Abstract Title

Presentation Details

Prof. Mengzhao
Wang

Sunvozertinib for the treatment of
NSCLC with EGFR Exon20 insertion
mutations: The first pivotal study results

Abstract #9002

Session Type: Oral

Oral Abstract Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 6, 2023, 10:09 AM-10:21AM CDT

Venue: Hall D1

Prof. Qingqing
Cai

Golidocitinib in treating refractory or
relapsed peripheral T-cell lymphoma:
Primary analysis of the multinational
pivotal study results (JACKPOT8)

Abstract #7503

Session Type: Oral

Oral Abstract Session

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session

Date and Time: June 6, 2023, 10:45 AM-10:57 AM CDT

Venue: S100a

Prof. Yan Xu

Efficacy and safety of sunvozertinib
in treatment naïve NSCLC patients
with EGFR exon20 insertion mutations

Abstract #9073

Poster Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 4, 2023, 08:00 AM-11:00 AM CDT

Venue: Hall A

Prof. James
Chih-Hsin Yang

Anti-tumor activity of sunvozertinib
in NSCLC with EGFR sensitizing
mutations after failure of EGFR TKI
treatment

Abstract #9103

Poster Session

Lung Cancer – Non-Small Cell Metastatic

Session

Date and Time: June 4, 2023, 08:00 AM-11:00 AM CDT

Venue: Hall A

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is a rationally designed, irreversible EGFR inhibitor targeting various EGFR mutations with wild-type EGFR selectivity. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary objective, demonstrating superior anti-tumor efficacy in pretreated NSCLC patients with EGFR Exon20ins. The confirmed objective response rate (cORR) at 300 mg was 60.8% assessed by IRC (Data cut-off date: October 17, 2022). Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. Two multinational pivotal studies are ongoing in ≥ 2nd line (WU-KONG1) and 1st line settings (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

Pre-clinical and Phase 1 clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022. The China NMPA has accepted NDA filing and granted priority review for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapy.

About Golidocitinib (DZD4205)

Golidocitinib (DZD4205) is an oral, potent, JAK1 selective inhibitor. It is the first JAK inhibitor which has moved into the stage of pivotal clinical development. In phase 1 study (Data cut-off date: May 31, 2021), golidocitinib showed encouraging anti-tumor activity in patients with r/r PTCL, with an ORR of 42.9%, and among those responders, more than 50% achieved complete response. The longest duration of response was longer than 14 months.

Golidocitinib was granted Fast Track Designation by US FDA in February 2022.

On May 25, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that the latest results from the Phase I/II TORCH-2 study will be presented as a poster at the 2023 American Society for Clinical Oncology Annual Meeting (ASCO 2023) taking place from June 2nd to 6th, 2023 at the McCormick Place Convention Center in Chicago, IL (Press release, Antengene, MAY 25, 2023, View Source [SID1234632097]). Being among the 22 China studies selected for Poster Discussions this year, the abstract will also be presented in a Poster Discussion session on June 3rd.

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"It is our pleasure to have the latest results from the TORCH-2 study selected for Poster Discussion at ASCO (Free ASCO Whitepaper) 2023," said Dr. Amily Zhang, Antengene’s Chief Medical Officer. "Going forward, we will maintain close collaboration with the investigator team of the TORCH-2 study and liaise with regulatory authorities in China and other APAC markets to align on a registration path in cervical cancer and to continue evaluating the combination in additional ongoing studies in other solid tumors."

The TORCH-2 study is a Phase I/II trial of the mTORC1/2 inhibitor ATG-008 plus the Anti-PD-1 monoclonal antibody toripalimab for the treatment of patients with advanced solid tumors. The study enrolled 46 patients, including 21 patients with cervical cancer, to evaluate ATG-008 at three doses (15, 20 and 30 mg) in combination with the standard dose of toripalimab. Study patients had advanced solid tumors with a baseline Eastern Cooperative Oncology Group (ECOG) score of 0-1 (the majority scored 1 on the ECOG scale) and a median of 2 lines of therapy (range:0-7). Median patient age was 53 years. Patients with prior PI3K/AKT/mTOR therapy were excluded. Pharmacokinetics and exploratory biomarkers of drug activity were also evaluated. The data are presented as of the cut-off date of October 21st, 2022.

Poster Details
Title: A phase I/II study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors

Abstract: 2526
Session: Developmental Therapeutics – Immunotherapy
Poster: 368
Poster Discussion Session Date and Time: 3:00 PM – 4:30 PM, June 3, 2023 (Central Time) / 4:00 AM – 5:30 AM, June 4, 2023 (Beijing Time)

52.4% ORR in the Cervical Cancer Cohort: Among the 21 patients in the cervical cancer cohort, 1 patient with negative PD-L1 expression experienced a CR and 9 patients experienced a partial response (PR). Note that the patient who achieved a CR in this cohort remained on treatment for more than 883 days and is on treatment with single agent ATG-008 as of the cut-off date. The mPFS for the cohort was 7.2 months.
Additional Responses in Patients with Nasopharyngeal Carcinoma (NPC): The study reported one additional PR in a patient with NPC; this patient remained on study for over two years.
Recommended Phase II Dose (RP2D) was Defined: The RP2D for ATG-008 was determined to be 15 mg in combination with toripalimab.
Safety Evaluation Did Not Identify any Dose-Limiting Toxicity (DLT) or Maximum Tolerated Dose (MTD) from the Dose Escalation Phase: The study did not identify any DLT or reach the MTD; 97.8% of patients had more than one treatment emergent adverse event (TEAE) and 69.6% of patients had TEAEs > grade 3, most common of which were decreased lymphocytes (23.9%), rash (10.6%) and hyperglycemia (10.9%). Pharmacokinetic profiles of ATG-008 in combination with toripalimab were similar to ATG-008 monotherapy across APAC and US patients. No new safety signals were reported.
About ATG-008

ATG-008 (onatasertib) is an orally available mTORC 1/2 inhibitor. ATG-008 inhibits the activity of mTOR, which may result in the induction of tumor cell apoptosis and a decrease in tumor cell proliferation. mTOR, a serine/threonine kinase that is upregulated in a variety of tumors, has an important role in the PI3K/AKT/mTOR signaling pathway, which is frequently dysregulated in human cancers. ATG-008 has been studied in clinical trials to treat a broad range of tumor types including multiple myeloma (MM), glioblastoma (GBM), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), diffuse large B-cell lymphoma (DLBCL), etc.