Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

Rhea-AI Summary

Roche has received FDA approval for the VENTANA CLDN18 (43-14A) RxDx Assay, the first companion diagnostic to identify patients with gastric and gastroesophageal junction (GEJ) cancer eligible for targeted treatment with VYLOY. This immunohistochemistry (IHC) assay helps determine CLDN18 protein expression in tumors, enabling clinicians to identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).

The assay addresses an unmet medical need by helping predict the likelihood of response to targeted therapy in gastric and GEJ cancers. CLDN18.2 is an emerging biomarker in these cancers. This approval aligns with current guidelines recommending biomarker use to guide therapeutic decision-making in gastric/GEJ cancer.

Gastric cancer is the fifth most common cancer and fourth leading cause of cancer deaths worldwide. In the U.S., 62% of gastric/GEJ cancer cases are advanced at initial diagnosis, with a five-year overall survival rate of only 6%.

Positive

• FDA approval of VENTANA CLDN18 (43-14A) RxDx Assay as the first companion diagnostic for gastric and GEJ cancer
• Enables identification of patients eligible for targeted treatment with VYLOY
• Addresses unmet medical need in gastric and GEJ cancer treatment
• Aligns with current guidelines for biomarker use in therapeutic decision-making

Negative

• None.

Insights

Medical Research Analyst

The FDA approval of Roche's VENTANA CLDN18 (43-14A) RxDx Assay marks a significant advancement in personalized medicine for gastric and gastroesophageal junction (GEJ) cancer patients. This companion diagnostic test identifies patients with CLDN18.2-positive tumors, who may benefit from targeted therapy with VYLOY (zolbetuximab).

Key points to consider:

• This is the first FDA-approved IHC companion diagnostic for CLDN18 protein expression in gastric/GEJ cancers.
• CLDN18.2 is an emerging biomarker that can predict response to targeted therapy.
• The assay addresses an unmet medical need in a cancer type with poor prognosis (6% 5-year survival rate for advanced cases).
• It aligns with current guidelines recommending biomarker-guided treatment decisions.

For investors, this approval strengthens Roche's position in the companion diagnostics market and supports its personalized healthcare strategy. It also opens up a new revenue stream in the gastric/GEJ cancer diagnostic space, potentially driving growth in Roche's diagnostics division.

Oncology Expert

The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is a pivotal development in gastric and GEJ cancer treatment. Here's why it's significant:

• Gastric cancer is the 4th leading cause of cancer deaths worldwide, with treatment options for advanced cases.
• 62% of gastric/GEJ cancers in the U.S. are diagnosed at an advanced stage, underscoring the need for effective therapies.
• VYLOY, the companion drug, is the first FDA-approved treatment specifically targeting CLDN18.2-positive, HER2-negative advanced gastric/GEJ cancers.
• This diagnostic-treatment combination exemplifies the shift towards precision oncology.

The assay's ability to identify CLDN18.2-positive tumors could significantly impact treatment decisions and potentially improve outcomes for a subset of patients. It's a step forward in addressing the challenges of late-stage diagnosis and poor survival rates in gastric/GEJ cancers.

• The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option.
• CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy.
• As the leader in companion diagnostics, Roche continues to build on its commitment to improve personalised healthcare to enable better patient outcomes.

TUCSON, Ariz., Oct. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANA^Ⓡ CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOY^TM (zolbetuximab).

"Patients who are diagnosed with gastric or gastroesophageal junction cancer are often diagnosed in an advanced stage as early symptoms can be similar across several conditions," said Jill German, Head of Pathology Lab at Roche Diagnostics. "Our companion diagnostic for CLDN18 can help identify patients eligible for targeted treatment and provide them with additional therapeutic options. With the launch of this test, Roche continues to advance personalised healthcare by expanding our innovative companion diagnostic portfolio."

Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making. The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy. VYLOY is the first FDA-approved treatment specifically targeting HER2-negative locally advanced unresectable or metastatic gastric or GEJ cancer patients whose tumours are CLDN18.2-positive.

Gastric cancer is the fifth most common cancer and the fourth leading cause of cancer deaths worldwide.¹ In the U.S., 62% of gastric/GEJ cancer cases are advanced when initially diagnosed, contributing to a five-year overall survival rate of only 6%.^2,3 Although gastric/GEJ cancer is less prevalent in the U.S. than in other parts of the world, it is often diagnosed late as signs and symptoms are common to other conditions.⁴

About the VENTANA CLDN18 (43-14A) RxDx Assay
The VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of Claudin 18 (CLDN18) protein in gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY® (zolbetuximab) in accordance with the approved therapeutic product labelling. The Roche test measures expression of both variants of the CLDN18 protein (18.1 and 18.2 isoforms). CLDN18.2 is the predominant variant expressed in gastric and GEJ cancers.^5,6

The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on the results of the SPOTLIGHT and GLOW clinical studies where it was used as the enrollment assay to identify patients whose tumours were CLDN18.2 positive. CLDN18.2 positivity is defined as ≥ 75% of tumour cells demonstrating moderate to strong membrane CLDN18 staining as measured by the VENTANA CLDN18 (43-14A) RxDx Assay.  In these studies, approximately 38% of gastric/GEJ cancer patients expressed high levels of CLDN18 and were considered CLDN18.2 positive by the VENTANA CLDN18 (43-14A) RxDx Assay. Patients who received a combination of zolbetuximab and chemotherapy experienced a 25-31% reduction in disease progression or death.^7,8

About Roche 
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

^{All trademarks used or mentioned in this release are protected by law.}

References

[1] Sung H et al. CA Cancer J Clin 2021;71:209-49.
[2] ACS. Cancer Facts & Figures 2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Accessed 01-12-2022.
[3] NCI SEER Cancer stat facts: stomach cancer. https://seer.cancer.gov/statfacts/html/stomach.html. Accessed 11-30-2023.
[4] National Cancer Institute. Gastric Cancer Treatment (PDQ®)-Patient Version. Accessed at https://www.cancer.gov/types/stomach/patient/stomach-treatment-pdq on March 8, 2023.
[5]  Saito, T. Matsuda, D. Moran, P-114 Claudin 18 isoform expression in gastric  adenocarcinoma and pancreatic adenocarcinoma, Annals of Oncology, Volume 32, Supplement 3, 2021, Page S138, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2021.05.169.
[6]VENTANA® CLDN18 (43-14A) RxDx Assay Package Insert, 2023
[7] Astellas press release, Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium. https://www.astellas.com/en/news/26946. Accessed June 12, 2023.
[8] Astellas press release, Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series. https://www.astellas.com/en/news/27481. Accessed June 12, 2023.

Roche Media Relations
Jo Lynn Garing, 317-363-7286
jo_lynn.garing@roche.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-the-first-companion-diagnostic-to-identify-patients-with-gastric-and-gastroesophageal-junction-cancer-eligible-for-targeted-treatment-with-vyloy-302280715.html

SOURCE Roche

FAQ

What is the purpose of Roche's newly FDA-approved VENTANA CLDN18 (43-14A) RxDx Assay for RHHBY?

The VENTANA CLDN18 (43-14A) RxDx Assay is a companion diagnostic to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may be eligible for targeted treatment with VYLOY (zolbetuximab).

How does the VENTANA CLDN18 (43-14A) RxDx Assay work for RHHBY's gastric cancer diagnostics?

The assay determines CLDN18 protein expression in tumors using immunohistochemistry (IHC), helping predict the likelihood of patients benefiting from CLDN18.2 targeted therapy.

What is the significance of CLDN18.2 in gastric and GEJ cancers for RHHBY's new diagnostic?

CLDN18.2 is an emerging biomarker in gastric and GEJ cancers that helps predict the likelihood of response to targeted therapy, making it valuable for treatment decisions.

What are the current statistics on gastric cancer diagnosis and survival rates relevant to RHHBY's new assay?

Gastric cancer is the fifth most common cancer worldwide. In the U.S., 62% of gastric/GEJ cancer cases are advanced at initial diagnosis, with a five-year overall survival rate of only 6%.