On June 10, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the European Commission has approved a Chugai originated anaplastic lymphoma kinase (ALK) inhibitor Alecensa (generic name : alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]) (Press release, Chugai, JUN 10, 2024, View Source [SID1234644221]). Data from the Phase III ALINA trial, where Alecensa demonstrated a 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.1

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"We are very pleased that Alecensa, a Chugai originated medicine, received approval in Europe following the U.S. approval for adjuvant treatment of ALK-positive early-stage NSCLC. We believe that this approval will have a significant impact, providing a new treatment opportunity for patients who have dealt with the risk of recurrence even after undergoing tumor resection. We remain committed to working with Roche to bring the benefits of this drug to patients around the world." said Chugai’s President and CEO, Dr. Osamu Okuda.

In the ALINA study, Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.1 In an exploratory analysis, an improvement of central nervous system disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58) compared with platinum-based chemotherapy.1 This is of particular importance for people with ALK-positive NSCLC, who are at greater risk of developing brain metastases than those with other types of NSCLC.2 The safety and tolerability of Alecensa in the ALINA trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1 These data were published in the New England Journal of Medicine in April 2024.

Alecensa is the preferred treatment option for patients with advanced ALK-positive NSCLC. Approved in more than 100 countries as a first- and second-line treatment, more than 94,000 patients with advanced disease have been treated with Alecensa in clinical practice. Following its approval in the adjuvant treatment setting, Alecensa could play a pivotal role in ALK-positive resectable disease, where there is a significant unmet medical need. Today’s approval in Europe follows the April 2024 U.S. Food and Drug Administration (FDA) approval of Alecensa as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. Submissions to additional health authorities worldwide are ongoing to bring this new treatment option to as many patients as possible.

To support clinicians’ decision-making, testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and selected IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines).

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, for people with NSCLC whose tumors are identified as ALK-positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China. Alecensa was approved by the U.S. Food and Drug Administration (FDA) in April 2024 as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test, and in June 2024 by the European Commission, as a monotherapy for adjuvant treatment following tumor resection for adult patients with ALK-positive NSCLC at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]). In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.3 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.3 In Japan, 127 thousand people are affected by this disease (2019).4 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.6 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.7

Trademarks used or mentioned in this release are protected by law.

On June 10, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported the completion of patient enrollment for STAR-221, a Phase 3 study in collaboration with Gilead Sciences, evaluating the combination of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (Press release, Arcus Biosciences, JUN 10, 2024, View Source [SID1234644237]).

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"STAR-221 completed enrollment well ahead of schedule, driven by significant interest from the global medical community in the potential for an anti-TIGIT-based regimen to address the high unmet need in this setting," said Dimitry S.A. Nuyten, M.D., Ph.D., chief medical officer of Arcus Biosciences. "Domvanalimab is the first and only anti-TIGIT antibody to be studied in a Phase 3 trial in upper gastrointestinal adenocarcinoma. We are now preparing for the readout and look forward to the potential opportunity to make a meaningful difference for patients with this disease."

Earlier this month at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Arcus and Gilead presented results from Arm A1 of the Phase 2 EDGE-Gastric study evaluating the same regimen in the same setting as the STAR-221 Phase 3 study. Data from this arm of EDGE-Gastric showed that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival (PFS) of 12.9 months, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone. Notably, nearly 60% of patients in the EDGE-Gastric study achieved PFS at 12 months, and the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained improvement across efficacy measures, including in those patients who have low PD-L1 expression. No unexpected safety signals were observed at the time of data cutoff, March 12, 2024. The domvanalimab plus zimberelimab and chemotherapy regimen was generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date.

Domvanalimab and zimberelimab are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal cancers have not been established.

About the STAR-221 Study

The ongoing, global STAR-221 trial (NCT05568095) enrolled approximately 1,050 participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The primary endpoints of the study are overall survival in PD-L1-high tumors and in the intent-to-treat population (all PD-L1 levels); secondary endpoints include progression-free survival, objective response rate and duration of response. Participants were randomized 1:1 between two arms:

1600 mg of domvanalimab intravenously (IV) every four weeks plus 480 mg of zimberelimab IV every four weeks plus FOLFOX (oxaliplatin, leucovorin, fluorouracil) every two weeks or 1200 mg of domvanalimab plus 360 mg of zimberelimab every three weeks plus CAPOX (capecitabine and oxaliplatin) every three weeks
240 mg of nivolumab IV every two weeks plus FOLFOX every two weeks or 360 mg of nivolumab plus CAPOX every three weeks
About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab, as well as other investigational cancer immunotherapies and A2a/A2b adenosine receptor antagonist etrumadenant, in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing and planned early and late-stage clinical studies in combination with other immunotherapies, including investigational Fc-silent anti-TIGIT monoclonal antibody domvanalimab and A2a/A2b adenosine receptor antagonist etrumadenant.

Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

On June 10, 2024 InDex Pharmaceuticals Holding AB (publ) (under name change to Flerie AB) ("InDex Pharmaceuticals" or the "Company") reported that the reverse merger with Flerie Invest AB ("Flerie"), pursuant to the agreement entered into and announced on May 20, 2024, has been completed (Press release, InDex Pharmaceuticals, JUN 10, 2024, View Source [SID1234644222]). As a result thereof, the Company changes its name to Flerie AB and a new board and management take office.

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Completion of the reverse merger
On May 20, 2024 InDex Pharmaceuticals entered into a conditional agreement, to acquire all shares in Flerie (the "Transaction"). The Transaction constitutes a so-called reverse merger whereby Flerie becomes a wholly-owned subsidiary of InDex Pharmaceuticals.

The completion of the Transaction was, among other things, conditional upon resolutions at extraordinary general meetings of the Company. The extraordinary general meetings, held on June 10, 2024, resolved to adopt all of the board’s proposed resolutions related to the Transaction. The resolutions are further described in the bulletin from the meetings that was announced by the Company earlier today. In addition to the resolutions at the extraordinary general meetings, the Company and Flerie agree that all other conditions of the Transaction have been fulfilled. The Transaction has therefore today been completed.

The purchase price in the Transaction has been paid through an issue in kind of 6,073,952,948 new shares in the Company (the "Consideration Shares"). The Consideration Shares have been subscribed for by the former shareholders of Flerie in exchange for all shares in Flerie. Following registration of the Consideration Shares, the former shareholders of Flerie will initially hold approximately 91.9 per cent of the total number of shares and votes in the Company, prior to completion of the capital raise outlined in the company description published by the Company on May 27, 2024.

At the extraordinary general meetings held today June 10, 2024, it was, among other things, resolved to change the company name of the Company to Flerie AB and to appoint Thomas Eldered, Cecilia Edström, Anders Ekblom and Jenni Nordborg as new board members of the Company, with Thomas Eldered as chairman. Flerie’s CEO Ted Fjällman has been appointed CEO of the Company and Flerie’s CFO and deputy CEO Cecilia Schéele has been appointed CFO and deputy CEO of the Company.

Company description
Following completion of the Transaction, the Company’s business consists of the business currently conducted by Flerie. In light of the substantial change in operations that the Transaction entails, the Company published a company description on May, 27 2024 with information about, inter alia, Flerie, InDex Pharmaceuticals, and the Transaction. The company description is available on Flerie’s website: www.flerie.com.

Admission to trading on Nasdaq Stockholm
In connection with completion of the Transaction, the Company intends to carry out an uplisting from Nasdaq First North Growth Market to Nasdaq Stockholm. The Company will prepare and publish a prospectus for admission to trading of the Company’s share on Nasdaq Stockholm. The prospectus is intended to be registered by the Swedish Financial Supervisory Authority and published around June 26, 2024. The first day of trading on Nasdaq Stockholm is planned to take place around June 27, 2024.

On June 10, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the first patient has been dosed in the Company’s camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial (Press release, Repare Therapeutics, JUN 10, 2024, View Source [SID1234644238]).

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"Camonsertib has demonstrated a promising signal of prolonged progression free survival in patients with ATM-mutated NSCLC in our ongoing TRESR clinical trial. We are thrilled with the rapid and efficient expansion of this clinical trial with the treatment of the first patient less than one month from the return of camonsertib global rights to Repare," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "Our biomarker-driven approach with camonsertib monotherapy has the potential to address the high unmet need of over 5,000 patients with ATM-mutated NSCLC in the tumor recurrence setting, across the United States, UK and top four EU markets, where unfortunately, the current standard of care provides progression free survival of approximately four months and low response rates."

The TRESR (Treatment Enabled by SNIPRx) clinical trial (NCT04497116) is a multicenter, open-label, dose-escalation and expansion Phase 1/2 clinical trial to investigate safety and tolerability, pharmacokinetics, pharmacodynamics, and the anti-tumor activity of camonsertib alone or in combinations. The NSCLC expansion is expected to enroll up to 20 patients with ATR-inhibitor sensitizing mutations in NSCLC to study the efficacy of camonsertib at the recommended Phase 2 dose. With limited treatments for recurrent NSCLC, camonsertib offers a highly desirable oral therapy option with an established safety profile. Repare expects a potential data readout in the camonsertib monotherapy NSCLC expansion in 2025.

On June 10, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, reported data from the preclinical development of its novel first-in-class lead radiopharma program MNPR-101-Zr at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Toronto, Canada (Press release, Monopar Therapeutics, JUN 10, 2024, View Source [SID1234644223]). SNMMI is the premier educational, scientific, and research event in the radiopharma space. Monopar’s poster presentation can be found at the following link: View Source

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Monopar’s poster highlights the potential promise of both the urokinase plasminogen activator receptor (uPAR) as a radiopharma cancer target for solid tumors as well as MNPR-101 as a targeting agent against uPAR. The data presented demonstrate robust, durable tumor uptake of Zr-89 radiolabeled MNPR-101 (MNPR-101-Zr) in human tumor xenograft mouse models of triple-negative breast, colorectal, and pancreatic cancers. Monopar’s optimization of the MNPR-101-Zr construct achieved markedly higher tumor uptake and drug stability while minimizing accumulation in bone and healthy tissue.

Monopar recently initiated a first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr. The study is led by internationally recognized radiopharmaceutical physician Prof. Rodney Hicks, founder of the Melbourne Theranostic Innovation Centre (MTIC). Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.