On September 9, 2024 Circle Pharma, a clinical-stage biopharmaceutical company dedicated to discovering and developing cell-permeable macrocycle therapies, reported that it presented a digital poster at the 2024 World Conference on Lung Cancer (Press release, Circle Pharma, SEP 9, 2024, View Source;utm_medium=rss&utm_campaign=circle-pharma-announces-preclinical-data-poster-presentation-of-cid-078-a-first-and-only-in-class-cyclin-a-b-rxl-inhibitor-at-the-2024-world-conference-on-lung-cancer [SID1234646426]).

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CID-078, Circle Pharma’s first-and-only-in-class cyclin A/B RxL inhibitor, demonstrated single-agent tumor regressions in both small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC) preclinical models. Tumor models with high E2F targets and G2M checkpoint hallmark pathways scores and elevated levels of E2F1, cyclin B1 and ESPL1 demonstrate tumor growth inhibition and/or regression when treated with CID-078 dosed at clinically achievable doses. CID-078 activity correlated with E2F1 and ESPL1 expression and was consistent with the proposed mechanism of action of cyclin A/B RxL inhibition leading to DNA damage. The data suggest that CID-078 holds promise as a monotherapy for patients with these cancers, which will be evaluated in a phase 1 clinical trial.

The digital poster can be viewed here.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple xenograft models.

On September 9, 2024 Bristol Myers Squibb (NYSE: BMY) reported the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 to be held from September 13-17 in Barcelona, Spain (Press release, Bristol-Myers Squibb, SEP 9, 2024, View Source [SID1234646425]).

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"Our data at ESMO (Free ESMO Whitepaper) this year highlight BMS’ enduring impact in oncology and offer insights into our earlier-phase, next-generation assets," said Samit Hirawat, M.D. , executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We are proud to continue to expand our oncology leadership and showcase progress within our diversified pipeline, including novel ADCs and protein degraders, to advance the next wave of breakthrough cancer treatments and offer more options for patients across a wide range of tumor types."

Key data being presented by Bristol Myers Squibb at ESMO (Free ESMO Whitepaper) Congress 2024 include:

Data supporting our innovative oncology portfolio

Ten-year follow-up data from the Phase 3 CheckMate –067 trial showed the continued durable, long-term survival benefit of Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with advanced or metastatic melanoma. These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial. (LBA43)
An update of clinical outcomes from the Phase 3 CheckMate -77T trial evaluating an Opdivo -based perioperative regimen in patients with resectable non-small cell lung cancer (NSCLC) (LBA50)
Expanded analyses from the CheckMate -9DW trial evaluating Opdivo plus Yervoy vs lenvatinib or sorafenib as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (965MO)
Subgroup efficacy and expanded safety data from the Phase 3 CheckMate –8HW trial evaluating Opdivo plus Yervoy as first-line treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) (541P)
Updated efficacy and safety results at approximately 15-months of follow up from the Phase 3 CheckMate –67T trial evaluating subcutaneous nivolumab in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (1691P)
Efficacy and safety data from the randomized Phase 3 KRYSTAL-12 trial evaluating KRAZATI (adagrasib) versus docetaxel in patients with pretreated locally advanced or metastatic NSCLC harboring a KRAS G12C mutation and baseline brain metastases (LBA57)
Studies supporting our advancing pipeline

Data from the proof-of-concept, randomized, Phase 2 RELATIVITY-104 trial evaluating the combination of nivolumab and relatlimab (1:1) plus platinum-doublet chemotherapy (PDCT) as first-line treatment for stage IV or recurrent NSCLC (LBA53)
BMS is initiating the Phase 3 RELATIVITY-1093 trial evaluating the fixed-dose combination of nivolumab and relatlimab (FDC 1:1) plus chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for patients with stage IV or recurrent non-squamous NSCLC with tumor cell PD-L1 expression of 1 to 49%, supported by findings from the RELATIVITY-104 trial
First data from the randomized, Phase 2 CA001-050 trial evaluating BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in newly diagnosed patients with extensive-stage small cell lung cancer: interim analysis (1786O)
Updated safety and clinical activity from first-in-human Phase 1 trial evaluating the targeted protein degrader BMS-986365, the company’s potential best-in-class oral dual androgen receptor ligand-directed degrader (AR LDD) and antagonist, in heavily pre-treated patients with metastatic castration-resistant prostate cancer (1597MO)
Three presentations of data evaluating BL-B01D1, a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 being developed in collaboration with SystImmune, Inc., in locally advanced or metastatic biliary tract cancer, locally advanced or metastatic urothelial carcinoma, and locally advanced or metastatic esophageal squamous cell carcinoma (54P, 1959O and 1426P)
Bristol Myers Squibb will host an investor webcast on Saturday, September 14 at 20:00 CEST (2:00 p.m. EDT) to discuss advancements in our cancer pipeline, including key data at ESMO (Free ESMO Whitepaper). Company executives will provide an overview at the meeting and address inquiries from investors and analysts.

Investors and the general public are invited to listen to a live webcast at View Source and are urged to register prior to the webcast.

Those unable to register can access the live conference call by dialing in the U.S. toll-free +1 833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at View Source prior to the start of the conference call.

Please see below for Important Safety Information and full Prescribing Information for Opdualag (nivolumab and relatlimab-rmbw), Opdivo plus Yervoy, and KRAZATI .

Summary of Presentations:

Select Bristol Myers Squibb studies at the ESMO (Free ESMO Whitepaper) Congress 2024 include:

Abstract Title

Author

Presentation Type/#

Session Title

Session Date/Time

Gastrointestinal Cancers

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC): expanded analyses from CheckMate 9DW

Thomas Decaens

Mini oral

965MO

GI tumors, upper

Monday, September 16

08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT

Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): subgroup efficacy and expanded safety analyses from CheckMate 8HW

Thierry Andre

Poster

541P

Colorectal cancer

Monday, September 16

Onsite poster display

BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Liu Chang

Poster

1426P

Oesophagogastric cancer

Monday, September 16

Onsite poster display

BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Biliary Tract Carcinoma (BTC)

Zhihao Lu

Poster

54P

Biliary tract cancer, incl. cholangiocarcinoma

Monday, September 16

Onsite poster display

Real-World Data on the Use of Nivolumab plus Chemotherapy for Patients with Metastatic GC/GEJC/EAC: A Canadian Perspective

Mustapha Tehfe

Poster

1415P

Oesophagogastric cancer

Monday, September 16

Onsite poster display

Long-term management and outcomes in gastroesophageal cancer in Norway

Aleksander Kolstad

Poster

1459P

Oesophagogastric cancer

Monday, September 16

Onsite poster display

Genitourinary Cancers

BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (mUC)

Dingwei Ye

Oral

1959O

GU tumors, non-prostate

Friday, September 13

14:00-15:30 PM CEST / 8:00 – 9:30 AM EDT

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): updated efficacy and safety results from CheckMate 67T

Laurence Albiges

Poster

1691P

Renal cancer

Sunday, September 15

Onsite poster display

Clinical activity of BMS-986365 (CC-94676), a dual androgen receptor (AR) ligand-directed degrader and antagonist, in heavily pretreated patients (pts) with metastatic castration-resistant prostate cancer

Dana Rathkopf

Oral

1597MO

GU tumors, prostate

Monday, September 16

10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT

Real-world (RW) characteristics and outcomes in patients (pts) with muscle-invasive urothelial carcinoma (MIUC) treated with adjuvant nivolumab (NIVO) with or without neoadjuvant chemotherapy (NAC)

Ebrahimi Hedyeh

Poster

1992P

Urothelial cancer

Sunday, September 15

Onsite poster display

Novel serum glycoproteomic biomarkers predict response to nivolumab plus cabozantinib (NIVO+CABO) versus sunitinib (SUN) in advanced RCC (aRCC): analysis from CheckMate 9ER

David A. Braun

Mini oral

1694MO

GU tumors, non-prostate

Sunday, September 15

08:30-10:00 CEST / 2:30-4:00 AM EDT

Health-related quality of life from the CheckMate 901 trial of nivolumab as first-line therapy for unresectable or metastatic urothelial carcinoma

Jens Bedke

Oral

1960O

GU tumors, non-prostate

Monday, September 16

08:30-10:00 AM CEST / 2:30 – 4:00 AM EDT

Melanoma

Ten-year survival outcomes of the CheckMate 067 phase 3 trial of nivolumab plus ipilimumab in advanced melanoma

James Larkin

Mini Oral

LBA43

Melanoma and other skin tumors

Sunday, September 15

14:45 – 16:15 CEST / 8:45 – 10:15 AM EDT

Nivolumab plus relatlimab vs nivolumab in previously untreated metastatic or unresectable melanoma: 3-year subgroup analyses from RELATIVITY-047

Dirk Schadendorf

Poster

1092P

Melanoma and other skin tumors

Saturday, September 14

Onsite poster display

Adjuvant nivolumab v placebo in stage IIB/C melanoma: 3-year results from CheckMate 76K

Georgina Long

Mini Oral

1077MO

Melanoma and other skin tumors

Sunday, September 15

14:45 – 16:15 CEST / 8:45 – 10:15 AM EDT

Thoracic Cancers

Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: results from the randomized phase 2 RELATIVITY-104 study

Nicolas Girard

Oral

LBA53

NSCLC, metastatic

Saturday, September 14

08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT

Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: clinical update from the phase 3 CheckMate 77T study

Mariano Provencio

Mini-oral

LBA50

Non-metastatic NSCLC

Sunday, September 15

10:15 – 11:30 CEST / 4:15 – 5:30 AM EDT

Adagrasib versus docetaxel in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC and baseline brain metastases: results from KRYSTAL-12

Fabrice Barlesi

Mini-oral

LBA57

NSCLC metastatic

Saturday, September 14

10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT

BMS-986012 (anti-fucosyl-monosialoganglioside-1 [Fuc-GM1]) with carboplatin + etoposide (CE) + nivolumab (N) as first-line therapy in extensive-stage small cell lung cancer (ES-SCLC): interim analysis (IA) of a randomized phase 2 study

Ewa Kalinka

Oral

1786O

Non-metastatic NSCLC

Friday, September 13

14:00 – 15:30 CEST / 8:00 – 9:30 AM EDT

Association between early endpoints and survival outcomes in neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC): A multi-country retrospective study

Mariano Provencio Pulla

Poster

1230P

NSCLC, early stage

Saturday, September 14

Onsite poster display

Real-world immunotherapy (IO) rechallenge outcomes with nivolumab (NIVO) in advanced non-small cell lung cancer (aNSCLC) in France: LIST study interim results

Benoit Bodbert

Poster

1317P

NSCLC, metastatic

Saturday, September 14

Onsite poster display

Expression Analysis of Fuc-GM1 Ganglioside in First-Line Therapy for Extensive-Stage Small Cell Lung Cancer (ES-SCLC) with BMS-986012, Nivolumab, and Carboplatin-Etoposide

Kenneth J. O’Byrne

Poster

1801P

SCLC

Saturday, September 14

Onsite poster display

KRYSTAL-7: a phase 3 study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation

Marina C. Garassino

Poster

1394TiP

NSCLC, metastatic

Saturday, September 14

Onsite poster display

Real-world treatment and overall survival (OS) in patients (pts) with ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in England between 2014 and 2023

Alistair Greystoke

Poster

1291P

NSCLC, metastatic

Saturday, September 14

Onsite poster display

Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA

A. Dietz

Poster

873P

Head and neck cancer, excluding thyroid

Saturday, September 14

Onsite poster display

All regular abstracts, except late-breaking abstracts, are available on the ESMO (Free ESMO Whitepaper) Congress 2024 website as of 00:05 CEST on Monday, September 9. All late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) Congress 2024 website at 00:05 CEST on the day of presentation.

On September 9, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX (Press release, BriaCell Therapeutics, SEP 9, 2024, View Source [SID1234646424]).

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"We are thrilled to be invited to present our data at this prestigious conference," stated Miguel Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "We look forward to continuing our investigations of novel targeted immunotherapy candidates in clinical studies with the goal of making a positive contribution to the lives of breast cancer and prostate cancer patients."

The details about the presentation and session Information are as follows:

Location: Exhibit Halls A B George R. Brown Convention Center, Houston, TX
Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST

Following the presentation, a copy of the poster will be posted on View Source

On September 9, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share new data for TEVIMBRA (tislelizumab) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress (ESMO 2024) in Barcelona, Spain, September 13-17, 2024 (Press release, BeiGene, SEP 9, 2024, View Source [SID1234646423]). BeiGene has seven abstracts accepted at ESMO (Free ESMO Whitepaper) 2024, with one selected for the special session revisiting the ESMO (Free ESMO Whitepaper) Virtual Plenary held in February 2024.

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New Data Add to Evidence for TEVIMBRA Across Multiple Disease States

As an encore to the ESMO (Free ESMO Whitepaper) plenary, interim results from the RATIONALE-315 study show the statistically significant event-free survival (EFS) and trend for overall survival (OS) benefit favoring neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab vs. placebo plus chemotherapy with adjuvant placebo for patients with resectable non-small cell lung cancer (NSCLC) (session #VP1-2024, Sept. 13 from 4:17-4:29 p.m. CEST). These results further reinforce the data presented at ESMO (Free ESMO Whitepaper) 2023 showing major pathologic response (MPR) and pathologic complete response (pCR) rate were significantly improved: 56.2% vs 15.0% (P<.0001) and 40.7% vs 5.7% (P<.0001), respectively. The safety profile of the tislelizumab arm was consistent with that of individual therapies, with 72.1% (vs. 66.4% in the placebo arm) of patients in the tislelizumab arm experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% (vs. 8.0% in the placebo arm) experiencing serious TRAEs. The most common TRAEs were decreased neutrophil count, decreased white blood cell count and alopecia. Improvement in symptomology from RATIONALE-315 will also be shown as patient-reported outcomes (poster #1213P, Sept. 14).
Three-year overall survival data from RATIONALE-305 continue to demonstrate the long-term efficacy and safety of tislelizumab plus chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) (poster #1437P, Sept. 16), as well as improvements in patient-reported outcomes (poster #1449P, Sept. 16).
Long-term outcomes in the ITT population as well as those receiving long-term exposure to tislelizumab plus chemotherapy as treatment for first line squamous NSCLC in RATIONALE-307 show a continued OS benefit with clinically promising four-year OS rates (poster #1323P, Sept. 14).
Relative effectiveness of tislelizumab vs. other anti-PD-1 treatments approved in the European Union and UK for second-line esophageal squamous cell carcinoma (ESCC) using anchored simulated treatment comparison of data from RATIONALE-302 and comparator clinical studies (poster #1417P, Sept. 16).
"TEVIMBRA has shown potential across multiple disease states, and the data at ESMO (Free ESMO Whitepaper) 2024 further supports its position as the foundational asset of our solid tumor portfolio," said Dr. med. Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene. "As part of our commitment to bring innovative cancer medicines to more patients, we recently launched TEVIMBRA in EMA-approved indications in Germany, Austria and Norway, and we are working to make TEVIMBRA available across Europe."

TEVIMBRA in Europe

BeiGene recently launched TEVIMBRA in the first European countries following EU marketing authorizations for the treatment of eligible patients with ESCC and NSCLC. TEVIMBRA is also approved in the UK and Switzerland for eligible patients with advanced or metastatic ESCC.

"Advanced or metastatic ESCC and NSCLC are aggressive cancers with limited treatment options," said Markus Moehler, M.D., Ph.D., of the Johannes Gutenberg University Medical Center Mainz in Germany. "The availability of tislelizumab for these patients represents an important next step to advance the treatment landscape."

The European Commission approvals were based on the results from four randomized Phase 3 studies in the RATIONALE program: RATIONALE-302 (NCT03430843) for ESCC and RATIONALE-307 (NCT03594747), RATIONALE-304 (NCT03663205) and RATIONALE-303 (NCT03358875) for NSCLC. The approved indications for TEVIMBRA in the EU are:

In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
About TEVIMBRA (tislelizumab)

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

On September 9, 2024 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported positive proof-of-concept randomized global Phase 1b FURTHER interim data for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at a Presidential Symposium Presentation at the IASCLC 2024 annual World Conference on Lung Cancer (WCLC), in San Diego, California (Press release, ArriVent Biopharma, SEP 9, 2024, View Source [SID1234646422]). ArriVent plans to host a virtual webinar on September 9, 2024 at 4:30 pm ET.

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"These compelling dose-dependent interim data are the first to demonstrate robust systemic and CNS anti-tumor activity for firmonertinib in a PACC mutant population," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We believe that the generally well-tolerated safety profile and response duration seen to date reinforce the therapeutic potential of firmonertinib to be an effective oral, chemotherapy-free treatment for this underserved patient population. Importantly, these data add to the clinical body of evidence supporting firmonertinib as a potentially effective option across EGFR mutation types and lines of non-small cell lung cancer therapy."

Presidential Symposium Presentation Highlights

Current standards of care have improved outcomes for classical EGFR mutations but have been less effective against uncommon EGFR mutation types including PACC and exon 20 insertion mutations which represent approximately 12% and 9% of NSCLC EGFR mutations, respectively. Firmonertinib, an oral, once-daily, highly brain-penetrant EGFR inhibitor with broad activity across EGFR mutations, was evaluated for interim clinical proof-of-concept data in first-line EGFR PACC mutant NSCLC as part of the Phase 1b FURTHER trial. Select clinical activity and safety results from FURTHER interim data analysis include:

· First clinical dataset from an EGFR inhibitor being tested in a randomized defined population of EGFR PACC mutant NSCLC

· Robust systemic and central nervous system (CNS) responses across patients observed as of June 20, 2024 (data cut):

o 81.8% at 240mg and 47.8% at 160mg overall response rate (ORR) by blinded independent central review (BICR)

o 63.6% and 34.8% confirmed ORR by BICR at 240mg and 160mg dose levels, respectively. One unconfirmed partial response pending confirmation at each of the 160mg and 240mg dose levels.

o Median duration of response had not yet been reached; 90.9% (n = 20/22) patients with confirmed responses remain on study

o 46.2% (n = 6/13) CNS confirmed ORR by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by BICR in first-line patients with brain metastases at baseline

· Generally well-tolerated with a profile consistent with prior firmonertinib data

o Most frequent treatment-related adverse events (TRAEs) were diarrhea, rash, dry skin, stomatitis, and hepatic enzyme elevation

o No treatment discontinuation due to TRAEs was observed

· Firmonertinib showed promising dose-dependent activity in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting and includes CNS antitumor activity consistent with its high brain penetrance.

Dr. Xiuning Le, Associate Professor of Thoracic Head and Neck Medical Oncology at MD Anderson Cancer Center and the lead Principal Investigator added, "Treating lung cancer patients with EGFR uncommon mutation lung cancer, including PACC mutations and exon 20 insertion mutations, remains a clinical challenge, as we need more potent and better tolerated EGFR inhibitors. These encouraging randomized data for firmonertinib suggest rapid and robust anti-tumor activity across PACC mutations which is similar to that observed for firmonertinib in exon 20 insertion mutations. Moreover, the apparent high CNS activity points to firmonertinib as a promising potential new therapy for frontline patients with PACC mutations including those with CNS disease.