On May 29, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that updated data from the global phase III study (the ALEX study) for Alecensa was presented on May 29 (local time) at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (Press release, Chugai, MAY 29, 2020, View Source [SID1234558654]). The ALEX study compared Alecensa and crizotinib as the first-line therapy for patients with ALK fusion gene positive non-small cell lung cancer (NSCLC).

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Abstract #9518;
Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC
View Source

Dr. Osamu Okuda, Chugai’s President and COO, said "This five-year follow-up data from the ALEX study shows the long-term benefits of Alecensa as the first-line treatment of ALK-positive NSCLC. This reaffirms the position of Alecensa as one of the standard treatments."

Latest data from the ALEX study shows:

At the updated data cut-off point, median duration of follow-up was 48.2 months (range: 0.5 – 62.7) and 23.3 months (range: 0.3 – 60.6) in the Alecensa and crizotinib arms, respectively. The number of overall survival (OS) events was 37% of the ITT population, median OS in the crizotinib arm was 57.4 months (95%CI: 34.6 – not estimable) and not estimable in the Alecensa arm (HR=0.67, 95％CI: 0.46 – 0.98). The 5-year survival rate was 62.5% (95%CI: 54.3 – 70.8) and 45.5% (95%CI: 33.6 – 57.4) in the Alecensa and crizotinib arms, respectively (secondary endpoint).
In patients with CNS metastases at baseline, the OS hazard ratio was 0.58 (95%CI: 0.34 – 1.00) and 0.76 (95%CI: 0.45 – 1.26) in patients without CNS metastases at baseline (secondary endpoint).
No new safety signals were observed, and the safety profile of Alecensa was consistent with previous reports.
Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.

[Reference information]

Media release issued by Roche on September 28, 2019:
Roche to present new and updated data at ESMO (Free ESMO Whitepaper) 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer
View Source
Media release issued by Roche on May 17, 2018:
Follow-up phase III data showed Roche’s Alecensa helped people with ALK-positive metastatic non-small cell lung cancer live a median of almost three years without their disease worsening or death
View Source
Trademarks used or mentioned in this release are protected by law.

On May 29, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported updated data from the pivotal phase III ALEX study, showing an increased five-year survival rate with Alecensa (alectinib), compared with crizotinib, in people living with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 29, 2020, View Source [SID1234558653]). These data confirm the longer-term efficacy of Alecensa already demonstrated across three phase III clinical trials. Full findings were presented at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Programme, on 29 May 2020.

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"These data further support Alecensa as the standard of care for people with metastatic ALK-positive NSCLC," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Importantly, these data show clinically meaningful benefit in people with or without central nervous system (CNS) metastases. These data, and our work in lung cancer more broadly, demonstrate our continued commitment to improving outcomes for people with this disease."

The updated results from the ALEX study show a five-year survival rate of 62.5% (95% CI: 54.3-70.8) in the Alecensa treatment group, versus 45.5% (95% CI: 33.6-57.4) with crizotinib.1 Despite longer median treatment duration, the safety profile of Alecensa remains favourable and consistent with previous data, with no new safety signals identified.1 The overall survival (OS) data, which are not yet mature, show a benefit in patients with CNS metastases at baseline (42% reduction in the risk of death versus crizotinib (95% CI: 0.34-1.00)), as well as in those without CNS metastases at baseline (24% reduction in the risk of death versus crizotinib (95% CI: 0.45-1.26)).1 These data follow on from the final, mature progression-free survival data from the ALEX study, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress in September 2019, which demonstrated a reduced risk of disease worsening or death by 57% (hazard ratio=0.43, 95% CI: 0.32–0.58) with Alecensa, versus crizotinib, in ALK-positive NSCLC.2 The updated data confirm the superior efficacy and tolerability of Alecensa in comparison to crizotinib.

Approximately 85% of lung cancer cases are NSCLC and, of these people, about 5% are ALK-positive.3,4 ALK-positive NSCLC is caused by a gene fusion or rearrangement that overactivates the ALK protein, driving cancer cell growth and survival.5 The disease often affects those who least expect it; 50% of patients are younger than 50 years and approximately 70% have never smoked.6,7,8

About the ALEX study
ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve patients with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. Patients were randomised (1:1) to receive either Alecensa or crizotinib. The primary endpoint of the ALEX study was progression-free survival (PFS) as assessed by the investigator, and secondary endpoints included: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (ORR), duration of response (DOR) and OS. The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data continue to be considered immature.

About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive.10 ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.6,7,8 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.11 Alecensa is now approved in 88 countries as an initial (first-line) treatment for ALK-positive, metastatic NSCLC, including in the US, Europe, Japan and China.10

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On May 28, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported it will present at the Jefferies Virtual Healthcare Conference 2020 on Thursday, June 4, 2020 at 9:00 a.m. EDT (Press release, Cue Biopharma, MAY 28, 2020, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-corporate-overview-and-pipeline-progress [SID1234608303]).

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Daniel Passeri, chief executive officer, will provide an overview of the Company’s Immuno-STAT (Selective Targeting and Alteration of T cells) and Neo-STAT platforms and an update on the on-going clinical trial for its lead drug candidate CUE-101, as well as pipeline progress and anticipated corporate development milestones. A live and archived version of the webcast will be available at View Source The presentation will also be archived for 30 days on the Company’s website.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On May 28, 2020 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) and Tavros Therapeutics, Inc., reported a strategic collaboration to apply Tavros’ functional genomic discovery platform to develop next generation targeted small molecule drug candidates, initially to expand Zentalis’ oncology pipeline (Press release, Zentalis Pharmaceuticals, MAY 28, 2020, View Source [SID1234578258]).

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"We are pleased to be collaborating with Zentalis, as this aligns with Tavros’ goal to improve cancer therapy by uncovering unique and druggable vulnerabilities within tumors," remarked Tavros CEO and co-founder Eoin McDonnell on behalf of Tavros co-founders Kris Wood and Greg Mossinghoff. "The Tavros functional genomic discovery platform employs proven technologies and proprietary know-how to significantly increase clinical success, as well as to improve the tolerability and toxicity profile of a new drug."

Tavros’ strategic approach allows for an unbiased analysis of intricate cellular signaling pathways to discover novel targets, synthetic lethality pairs, mechanisms to overcome cancer resistance, and unique genetic signatures for clinical trials.

Zentalis CEO Anthony Sun commented, "Tavros and Zentalis share a common goal: to utilize proprietary technologies to discover and develop drugs that are safer, more efficacious and tolerable for patients than existing therapies. Leveraging the unique insights provided by Tavros’ technologies coupled with Zentalis’ strong medicinal chemistry expertise, we believe this relationship could yield multiple novel drug candidates and combinations that may have the potential to address unmet needs for cancer patients."

The transaction terms were structured to build and expand the Tavros discovery platform, with each company given the rights to any new products generated from the platform.

On May 28, 2020 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that João Siffert, M.D., Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 10:00 a.m. ET (Press release, Abeona Therapeutics, MAY 28, 2020, View Source [SID1234561642]).

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A live webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com. The webcast replay will be available within 24 hours of the live presentation and will be accessible for 90 days.