On September 13, 2024 InnoCare reported the latest data of orelabrutinib were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (Press release, InnoCare Pharma, SEP 13, 2024, View Source [SID1234646591]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Presentation

A Prospective Study of Orelabrutinib plus Obinutuzumab (O2) in Treatment-naïve Marginal Zone Lymphoma (MZL): Preliminary Analysis on Efficacy and Safety (Abstract No.: 815MO)

This prospective study evaluated a chemotherapy-free regimen of orelabrutinib plus anti-CD20 antibody, obinutuzumab, in treatment-naive MZL.

Currently, there is no well-established standard first-line treatment for symptomatic MZL patients. The preliminary data demonstrated that the combination of orelabrutinib plus obinutuzumab shows promise in treatment-naive MZL. At a median follow-up of 5.4 months, the best objective response rate (ORR) was 100% (57.1% complete response rate (CRR)), with a good safety profile.

Poster Presentation

1. Orelabrutinib-based Regimens in Chronic Lymphocytic Leukemia with Comorbidities: A Real-World Study (Abstract No.: 840P)

This study aimed to evaluate the efficacy of orelabrutinib-based regimens for chronic lymphocytic leukemia (CLL) with comorbidities in a real-world setting. The outcome was the hematologic response (HR) rate. Orelabrutinib-based regimens demonstrated encouraging HR and were well tolerated in CLL with comorbidities, providing valuable insights for clinical management.

Eighty percent of patients have comorbidities. At a median follow-up of 12.7 months, 93.3% patients achieved an HR. Among the different orelabrutinib-based regimens, HR was achieved in 100% of patients receiving orelabrutinib monotherapy and 85.7% of those receiving orelabrutinib + chemotherapy. No serious adverse events occurred in the patients with comorbidities.

2. Efficacy and Safety of Orelabrutinib plus R-CHOP-like Regimens for Treatment-naïve Diffuse Large B-cell Lymphoma with Double Expression (Abstract No.: 819P)

The first-line combination of orelabrutinib plus R-CHOP-like regimens was effective and well-tolerated in patients with diffuse large B-cell lymphoma (DLBCL) harboring double expression.

The complete response rate (CRR) was 93.8% at the end of treatment. After a median follow-up of 13.0 months, the one-year progression-free survival (PFS) and overall survival (OS) rates were 93.3% and 100.0%, respectively.

The following studies were also selected as poster presentations at the ESMO (Free ESMO Whitepaper) Congress 2024.

Fixed-duration Orelabrutinib plus Bendamustine and Rituximab versus Continuous Bruton Tyrosine Kinase Inhibitor (BTKi) in Treatment-naïve Chronic/small Lymphocytic Leukemia (CLL/SLL): A Multicenter, Nonrandomized, Pragmatic Clinical trial (Abstract No.: 846TiP)
Orelabrutinib combined with Rituximab for the Treatment of Elderly patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL) under the guidance of genetic subtype: A prospective, multicenter, single-arm, response-adaptive clinical study (Origin) (Abstract No.: 844TiP)
For more detailed clinical data, please refer to ESMO (Free ESMO Whitepaper) website.

About Orelabrutinib

Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profiles.

On December 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into the National Reimbursement Drug list, allowing it to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition, orelabrutinib is being advanced in autoimmune diseases trials worldwide. A phase III registrational trial for the treatment of Primary Immune Thrombocytopenia purpura (ITP) is ongoing in China. A global phase II study for the treatment of Multiple Sclerosis (MS) has been completed, and a global multi-center phase III study for the treatment of Primary Progressive Multiple Sclerosis (PPMS) is being initiated. A phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, and the patient enrollment in the phase IIb trial is near completion; orelabrutinib is the first and only BTK inhibitor globally to show efficacy in phase II SLE trials. A phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.

On September 13, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the Company and its researchers will present data from multiple studies using Guardant technology to advance precision oncology at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, ​​Spain, September 13-17, 2024 (Press release, Guardant Health, SEP 13, 2024, View Source [SID1234646590]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data on the Guardant Reveal minimal residual disease test in patients with locally advanced rectal cancer enrolled in the NO-CUT trial will be presented in a presentation session at Presidential Symposium III. Additional presentations will focus on results from studies evaluating Guardant360 for treatment selection in advanced breast cancer and other solid tumors, as well as the Guardant Infinity response monitoring platform in advanced non-small cell lung cancer (NSCLC).

"Our latest data presented at ESMO (Free ESMO Whitepaper) further highlight the value of Guardant’s technology in precision oncology and the critical role liquid biopsy can play in informing therapy selection and treatment management across multiple tumor types," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "We look forward to demonstrating how Guardant’s tests can contribute to better outcomes across all stages of cancer care."

Full list of Guardant Health and collaborators’ presentations at ESMO (Free ESMO Whitepaper) 2024

Résumé

Title (translated from English) (Hall 6, unless otherwise indicated)

Product

Saturday, September 14 | 9:00 a.m. – 5:00 p.m.

1295P

EP0031, a next-generation selective RET inhibitor (SRI): correlation of molecular and clinical responses in patients with RET-positive solid tumors who are naïve or following prior SRI

Guardant Infinity

Sunday, September 15 | 9:00 a.m. – 5:00 p.m.

127P

Clinical utility of next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) to inform treatment decisions for patients with advanced solid tumors

360 guard

Monday, September 16 | 9:00 a.m. – 5:00 p.m.

418P

Concordance of PI3K-AKT pathway alterations between tumor and ctDNA in metastatic breast cancer

360 guard

419P

Prevalence of gene rearrangement on NGS ctDNA and its targeting in patients with advanced breast cancer

360 guard

Monday, September 16 | 5:04 p.m. – 5:16 p.m.

509O

Total neoadjuvant therapy (TNT) with non-operative therapy (NOM) for effective mismatch repair of locally advanced rectal cancer (pMMR LARC): first results of the NO-CUT trial

Proposed communications session: Presidential Symposium III: Looking to the Future, Auditorium Barcelona, ​​Hall 2

Saving Reveal

Full Guardant Health abstracts and a list of all abstracts presented at the ESMO (Free ESMO Whitepaper) Congress are available on the ESMO (Free ESMO Whitepaper) website .

Additional information and conference updates: Follow Guardant Health on LinkedIn , X (Twitter) and Facebook , or visit Guardant in person at booth #510.

On September 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotech company pioneering a new way to activate T cells targeting the Vβ chain of the T cell receptor to select the optimal T cell subsets against cancer, reported that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. to study the combination of STAR0602 (Invikafusp alfa) with Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate (ADC), as a potential treatment for adult patients with metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and metastatic triple-negative breast cancer (TNBC) (Press release, Marengo Therapeutics, SEP 13, 2024, View Source;breast-cancers-302247091.html [SID1234646582]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The planned combination trial, sponsored by Marengo, is expected to commence soon. This study will evaluate the safety, tolerability, and preliminary efficacy of STAR0602 (Invikafusp alfa) in combination with Trodelvy in patients with metastatic TNBC or metastatic HR+/HER2- breast cancer, aiming to explore a novel therapeutic strategy that could offer new treatment options for patients.

"We are excited about the clinical potential of combining our novel selective dual T cell activator with Gilead’s antibody-drug conjugate, Trodelvy," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "This innovative approach leverages the strengths of two unique modalities to target and potentially eradicate cancer cells more effectively. With the possibility to deliver target cytotoxic agents directly to tumors, which release more tumor antigens for selectively activated and expanded Vβ6/10 T cells to recognize and build long-term immune memory, we believe this combination may have the potential to improve cancer patient outcomes."

Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Marengo, who will conduct and sponsor the combination study. Marengo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established.

On September 13, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that its new drug Silmitasertib (CX-4945) was granted a rare pediatric disease designation (RPDD) by US FDA for the treatment of neuroblastoma (Press release, Senhwa Biosciences, SEP 13, 2024, View Source [SID1234646581]). This is the recognition obtained again after Silmitasertib (CX-4945) received RPDD in medulloblastoma from the FDA in July 2020, demonstrating the great potential of Silmitasertib (CX-4945) in the development of treatments for rare pediatric cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor that exhibited antitumor activity in pre-clinical study of neuroblastoma. The RPD designation will qualify the drug for the priority review voucher (PRV) program meant to encourage development of novel therapies for rare pediatric diseases. Silmitasetib has previously granted 1 RPD and 3 orphan drug designations (ODD) by the FDA.

"The RPD designation offers sponsors the additional incentive by requesting priority review vouchers (PRVs) for their future marketing applications, and this approach encourages the drug development for the treatment of rare pediatric diseases," said Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc.

Neuroblastoma, an embryonic tumor of the peripheral sympathetic nervous system, is the third most common pediatric cancer and the most common cancer in infants. It is mostly diagnosed in infancy at an average of 1 to 2 years old. There are an estimated 700 to 800 new cases of neuroblastoma each year in the United States.

While low and intermediate-risk neuroblastoma have a very high rate of survival, high-risk neuroblastoma has a 5-year survival rate of about 50%, and it has a high likelihood of recurrence even with intense multimodal treatments. There is currently no standard treatment for patients with relapsed/refractory neuroblastoma.

On September 13, 2024 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 13-17, 2024, in Barcelona, Spain (Press release, ESSA, SEP 13, 2024, View Source [SID1234646580]). Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company’s website at www.essapharma.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to be sharing more mature data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide today at ESMO (Free ESMO Whitepaper) 2024. The combination continues to be well tolerated with prolonged reductions in circulating prostate-specific antigen ("PSA") levels in patients with metastatic castration-resistant prostate cancer ("mCRPC"). After 15.2 months of follow up, neither median time to PSA progression nor radiographic progression free survival have been reached. These data compare favorably to historical data for single agent enzalutamide treatment in the mCRPC patient population," said David Parkinson, MD, President and CEO of ESSA. "We continue to focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 33 sites activated in the US, Canada and Australia and an additional 22 sites anticipated in Europe. We look forward to providing further updates in 2025."

Poster presentation details:

Title: Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared with Enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 results and Phase 2 design
Presenting Author: Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Presentation #: 1641P
Date and time: Sunday, September 15, 2024; 12:00-1:30 p.m. CEST/ 6:00-7:30 a.m. ET

Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today includes 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 32 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 88% of patients (14 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA <0.2ng/mL. With a current median follow up of 15.2 months, the median time to PSA progression and radiographic progression free survival have not yet been reached.

The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 33 sites in the USA, Canada and Australia, and an additional 22 sites anticipated in Europe.

About Masofaniten

Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.