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 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported completion of the first cohort of the Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of pediatric patients with lymphatic malformations (LMs) (Press release, Protara Therapeutics, SEP 9, 2024, https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-announces-completion-first-cohort-phase-2 [SID1234646439]). Enrollment is now underway in additional cohorts.

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"The initial data is compelling and reflective of the significant benefit observed in previous studies with OK-432, the predecessor of TARA-002," said Nancy Bauman, MD, Children’s National Medical Center: Children’s Research Institute, Washington DC, and investigator for the STARBORN-1 trial. "There is a pressing need for an effective therapeutic option for LMs, a rare condition mainly affecting children for which there are currently no U.S. FDA approved agents. I remain excited about the potential for TARA-002 to play a meaningful role in the treatment of these patients and look forward to future learnings from this important study."

Of three patients treated in the first cohort, which enrolled individuals six years to less than 18 years of age, two patients treated with TARA-002 achieved a complete response after receiving one dose of TARA-002; the responses were seen in a patient with a macrocystic lymphatic malformation and a patient with a ranula. The safety and tolerability seen in this cohort was consistent with that of the historical experience with OK-432 and included treatment emergent adverse events (TEAEs) of pain, swelling, fatigue, and body temperature increases. All TEAEs were mild to moderate and resolved.

"We are pleased with the progress of our Phase 2 STARBORN-1 trial and the encouraging results we have seen thus far," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We have received positive feedback from our investigators and already have a number of patients on waiting lists for our subsequent cohorts, and expect to share initial results from our next cohort in the first half of 2025."

STARBORN-1 is a Phase 2 single-arm, open-label, prospective clinical trial evaluating the safety and efficacy of intracystic injection of TARA-002 for the treatment of macrocystic and mixed cystic LMs (≥ 50% macrocystic disease) in participants six months to less than 18 years of age. The trial will enroll approximately 30 patients including age de-escalation safety lead-in cohorts of children ages six years to less than18 years, two years to less than six years, and six months to less than two years, who will receive up to four injections of TARA-002 spaced approximately six weeks apart.

The primary endpoint of the trial is the proportion of participants with macrocystic and mixed cystic LMs who demonstrate clinical success, defined as having either a complete response (90% to 100% reduction from baseline in total LM volume) or substantial response (60% to less than 90% reduction in total LM volume) as measured by axial imaging.

About TARA-002 in LMs

TARA-002 is an investigational cell therapy based on the broad immunopotentiator, OK-432, which was originally granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer therapeutic agent. This cell therapy is currently approved in Japan and Taiwan for LMs and has been used to successfully treat thousands of pediatric patients with this rare condition. In addition, OK-432 was studied in the largest ever conducted Phase 2 trials in LMs, in which the therapy was administered via a now-closed compassionate use program led by the University of Iowa.

TARA-002 has been granted Rare Pediatric Disease designation by the U.S. Food and Drug Administration (FDA) for the treatment of LMs.

About Lymphatic Malformations

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection; and cosmetic and other functional disabilities.

On September 9, 2024 Boehringer Ingelheim reported positive results from a Phase Ib primary analysis of Cohort 1 of the Beamion LUNG-1 trial evaluating zongertinib (BI 1810631) in pre-treated patients with advanced non-small cell lung cancer (NSCLC) with activating HER2 mutations (Press release, Boehringer Ingelheim, SEP 9, 2024, View Source [SID1234646455]). Zongertinib demonstrated a meaningful objective response rate and was generally well tolerated in the Cohort 1 setting. The results were presented in a Presidential Symposium at the IASLC 2024 World Conference on Lung Cancer (WCLC) and are included in the official 2024 WCLC Press Program.

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As of May 2024, 132 patients have been treated with 120 mg / 240 mg of zongertinib once a day (n=75/n=57). With a confirmed objective response rate (ORR) of 66.7%, 97.5% CI (53.8–77.5), (p<0.0001) as assessed by blinded independent central review (BICR), the primary endpoint was met for Cohort 1 (120 mg; n=75). Tumor shrinkage of any magnitude was observed in 94% of all patients across doses, per investigator assessment. The trial design includes a dose expansion that was carried out to find the optimal dose of zongertinib for this patient population. Patients were randomized 1:1 to either the 120 mg (n=58) or the 240 mg (n=55) group. After an interim futility analysis, 120 mg was selected as the dose to be evaluated further in Cohort 1, and 17 additional patients were enrolled. In the part of the trial where patients were randomized 1:1, zongertinib showed a response rate of 72.4% in patients treated with 120 mg daily, and 78.2% in patients treated with 240 mg daily as well as disease control rates (DCRs) of 95% and 100% respectively.

Phase Ib, Cohort 1 data also show preliminary brain activity with zongertinib. 33% (120 mg; n=27) and 40% (240 mg; n=25) of patients with asymptomatic brain metastases achieved confirmed objective response, with a DCR of 74% and 92% respectively, as per RANO-BM (recommendations for standardized tumor response and progression assessment) by BICR. The central nervous system is a common site of metastasis in NSCLC and is associated with poor prognosis and quality of life.2 Brain metastases are present in up to 30% of patients with NSCLC with activating HER2 mutations at diagnosis.3

"These new data could represent positive news in the future treatment of non-small cell lung cancer patients with activating HER2 mutations," said the trial’s principal investigator, Dr. John Heymach, MD, PhD, The University of Texas MD Anderson Cancer Center. "While these mutations are rare, they are critical drivers in a subset of non-small cell lung cancer cases, and current treatment options are severely limited. Patients with this type of cancer typically face a poor prognosis, with approximately 50% responding to first-line treatment and only 20% responding to second-line therapy." 4,5,6,7

Zongertinib is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development for patients with advanced NSCLC with activating HER2 mutations. Zongertinib was designed to spare wild-type EGFR thereby mitigating associated toxicities. Beamion LUNG-2, a global Phase III trial evaluating zongertinib compared to standard of care as first-line treatment in patients with advanced NSCLC with activating HER2 mutations is currently enrolling.

Paola Casarosa, Board of Managing Directors, Head of Innovation Unit at Boehringer Ingelheim, said: "Zongertinib’s efficacy and tolerability profile has the potential to become part of the future treatment landscape for patients with HER2 mutated lung tumors. Zongertinib is a perfect example of our approach to science in the discovery and development of novel treatments. Boehringer is committed to providing breakthrough therapies for cancer patients, and we look forward to advancing the zongertinib clinical program."

Zongertinib was generally well tolerated for 120 mg and 240 mg, with no deaths attributed to treatment and a low incidence of adverse events leading to dose reductions (11%) and discontinuation (3%). No new safety signals or treatment-related interstitial lung diseases (ILD) were observed, and Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 17% (120 mg) and 19% (240 mg) of patients treated with zongertinib. The most common TRAEs were Grade 1 or 2 diarrhea (43% and 11% respectively), Grade 1 or 2 rash (19% and 8% respectively).

Data are still maturing and with two thirds of responding patients still on treatment at data cut-off, progression-free survival (PFS) and duration of response (DoR) data will be reported at an upcoming conference.

About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.8 NSCLC is the most common type of lung cancer.9 The condition is often diagnosed at a late stage,10 and fewer than 3 in 10 patients are alive five years after diagnosis.11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives. There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations).12 Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.13

About zongertinib
Zongertinib (also known as BI 1810631) is an investigational oral HER2-specific tyrosine kinase inhibitor (TKI) that is being developed as a potential treatment for HER2 mutated non-small cell lung cancer (NSCLC). Zongertinib was granted FDA Fast Track Designation in 2023, then in 2024 it was granted Breakthrough Therapy Designation by the U.S. FDA and China CDE for the treatment of adult patients with advanced NSCLC whose tumors have activating HER2 mutations, and who have received a prior systemic therapy. HER2 is a member of the ErbB family of receptor tyrosine kinases (enzymes that act like chemical messengers).14 A recent study has shown pre-clinically that the investigational compound zongertinib has potential for further clinical study in HER2 dependent solid cancers as monotherapy and as concurrent treatment with ADC therapy or with KRAS-targeted drugs.14 Read more here.

About the Beamion clinical trial program
Beamion LUNG-1 (NCT04886804): An open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 mutations. The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. Beamion LUNG-2 is a phase 3, open label, randomized, active-controlled study that will enroll 270 patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain mutations to evaluate zongertinib compared with standard of care.

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 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported five-year results from the final pre-specified overall survival (OS) analysis of the Phase 3 EMPOWER-Lung 1 trial, which evaluated Libtayo (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations (Press release, Regeneron, SEP 9, 2024, View Source [SID1234646440]). The late-breaking results will be presented in an oral session at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.

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"The five-year results from EMPOWER-Lung 1 showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with PD-L1 high, advanced NSCLC, including a direct correlation between survival benefits and PD-L1 expression level," says Ana Baramidze, MD, PhD, Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia. "Furthermore, EMPOWER-Lung 1 continues to offer important new data to help doctors increase their understanding of investigational treatment strategies for patients who progress on PD-1 inhibitor monotherapy. For instance, EMPOWER-Lung 1 was one of the few trials to evaluate survival when adding chemotherapy to a PD-1 inhibitor following progression."

At the five-year follow-up, Libtayo remained superior to chemotherapy in the population of patients confirmed to have ≥50% PD-L1 expression (using an FDA approved assay), demonstrating continued and clinically meaningful benefits consistent with the prior 1-year analysis in this study population (as previously published in The Lancet and also as previously provided in the approved label for the FDA-approved assay):

1-year Analysis 5-year Analysis
Libtayo
(n=283) Chemotherapy
(n=280) Libtayo
(n=284) Chemotherapy
(n=281)
Overall survival (OS)
Mediana not reached 14 months 26 months 13 months
Hazard ratio (HR)
(95% confidence
interval [CI]; p-value)b 0.57
(0.42 to 0.77; p=0.0002) 0.59
(0.48 to 0.72; p<0.0001)
Progression-free survival (PFS)
Mediana 8 months 6 months 8 months 5 months
HR (95% CI; p-value)b 0.54
(0.43 to 0.68; p<0.0001) 0.50
(0.41 to 0.61; p<0.0001)
Objective response
rate (ORR) 39% 20% 46.5% 21%
Median duration of
response (DoR) 17 months 6 months 24 months 6 months
NOTE: The analysis was conducted in a subset of the randomized population that excluded 147 patients whose tumors could not be retested or were later found to have <50% PD-L1 expression.
a Based on Kaplan-Meier method
b Based on stratified proportional hazards model

Continued and clinically meaningful benefits were also observed at this five-year follow-up of the overall trial population (in which not all patients were confirmed to have ≥50% PD-L1 expression), as compared to the prior 1-year analysis in this population.

1-year Analysis 5-year Analysis
Libtayo
(n=356) Chemotherapy
(n=354) Libtayo
(n=357) Chemotherapy
(n=355)
OS
Mediana 22 months 14 months 23 months 14 months
HR (95% CI; p-value)b 0.68
(0.53 to 0.87; p=0.0022) 0.64
(0.54 to 0.77; p<0.0001)
PFS
Mediana 6 months 6 months 6 months 5 months
HR (95% CI; p-value)b 0.59
(0.49 to 0.72; p<0.0001) 0.55
(0.46 to 0.66; p<0.0001)
ORR 37% 21% 42% 21%
Median DoR 21 months 6 months 24 months 6 months
a Based on Kaplan-Meier method
b Based on stratified proportional hazards model

Importantly, EMPOWER-Lung 1 allowed patients who experienced disease progression to change their therapy, with those assigned to Libtayo having the option to add four cycles of chemotherapy. Among these patients (n=75), the addition of chemotherapy was associated with a 15-month median OS (95% CI: 11 to 18 months), 7-month median PFS (95% CI: 6 to 8 months) and 28% ORR (95% CI: 18% to 40%).

The exploratory subgroup analysis of EMPOWER-Lung 1 also showed direct correlations between survival and disease progression benefits and PD-L1 expression level among Libtayo patients, supporting the direct correlation between tumor response and PD-L1 expression level previously observed. At five years, those with tumor PD-L1 expression of ≥90% (n=99) derived the greatest benefit with a median OS of 39 months (95% CI: 23 months to not evaluable) and a 15-month median PFS (95% CI: 10 to 21 months). These correlations with PD-L1 expression level were not observed with chemotherapy.

No new safety signals were observed at five years among evaluable patients (Libtayo=356; chemotherapy=343), following a median duration of exposure of 36 weeks to Libtayo and 18 weeks to chemotherapy. Adverse events (AEs) of any grade occurred in 93% of Libtayo patients (46% ≥Grade 3) and 96% of chemotherapy patients (52% ≥Grade 3). The most common AEs occurring in at least 10% of Libtayo patients included anemia (20%), decreased appetite (14%), fatigue (14%), pneumonia (12%), arthralgia (12%), back pain (12%), dyspnea (11%), cough (10%) and pruritus (10%). Among Libtayo patients, AEs were serious in 36% and led to permanent discontinuation in 9% and death in 10%, compared to 29%, 5% and 10% in the chemotherapy arm, respectively.

Among the 75 Libtayo patients who received additive chemotherapy after disease progression, AEs of any grade occurred in 89% (36% ≥Grade 3), following a median duration of exposure of 27 weeks to Libtayo. The most common AEs included anemia (35%), alopecia (24%), diarrhea (21%), nausea (20%), neutropenia (15%) and asthenia (11%). AEs were serious in 27% of patients and led to discontinuation of treatment in 5% of patients and death in 4% of patients.

Additional presentations on data from Regeneron’s oncology portfolio and pipeline are being shared at WCLC.

The potential use of adding chemotherapy to Libtayo following disease progression as described above is investigational, and the safety and efficacy of this regimen have not been fully evaluated by any regulatory authority.