‘Dramatic Response Rates Without Compromising Quality of Life’: New FDA-Approval Offers Promising Option For Rare Lung Cancer Subtype

WATCH: Molecular Testing: How Genetic Testing Shapes Lung Cancer Care

Tyrosine kinase inhibitors work by blocking enzymes that help regulate cell growth and survival. Some cancers rely on overactive kinases, and shutting them down can slow or stop tumor growth, according to the National Cancer Institute.

“It’s a great TKI drug with meaningful impact for patients with HER2‑mutant lung cancer,” Dr. Raja Flores, a leader in thoracic surgery with Mount Sinai Health System, tells SurvivorNet.

The Beamion LUNG‑1 trial, which led to the FDA approval of the drug, illustrated how zongertinib can lead to dramatic and durable responses for these patients.

“Zongertinib is the first FDA-approved targeted therapy for HER2‑mutant advanced non-small cell lung cancer as an initial treatment option,” Dr. Josh Sabari, a medical oncologist specializing in lung cancer at NYU Langone’s Perlmutter Cancer Center and principal investigator on the Beamion LUNG‑1 trial, tells SurvivorNet.

He adds that he has seen “dramatic response rates and durability of response without compromising quality of life.”

What Do The Data Show?

The Beamion LUNG‑1 study enrolled 72 patients with unresectable or metastatic, non‑squamous NSCLC who had not received prior systemic therapy.

Objective response rates, or the percentage of people in a study who had either a partial or complete response during a measured amount of time, trended very well.

• Zongertinib produced an objective response rate of 76%
• 64% of responders maintained benefit for at least six months
• 44% of responders maintained benefit for at least a year

Dosing for the drug is based on body weight. Patients under 90 kg (198 lbs) are given 120 mg once daily and patients 90 kg or above are given 180 mg once daily.

Dr. Sabari adds that zongertinib’s manufacturer, Boehringer Ingelheim, received a breakthrough designation and a Commissioner’s National Priority Voucher, expediting the FDA review because of the significant unmet need for HER2‑targeted options in the frontline setting.

WATCH: Next Generation Sequencing: When is a Liquid Biopsy Recommended for Lung Cancer?

Dr. Flores notes that approvals like this strengthen the broader treatment landscape.

“As surgeons, we welcome these newer therapies because they enhance the multimodality approach — integrating effective systemic treatment with surgery and radiation to improve outcomes,” he adds.

Diagnosing & Treating Lung Cancer

Lung cancer forms when cancer cells develop in the tissues of the lung. It is the second most common form of cancer and the leading cause of cancer deaths in both men and women in the U.S. The challenge with diagnosing and treating early stems from how the disease tends to behave.

It’s “completely asymptomatic,” says Dr. Joseph Friedberg, thoracic surgeon in chief at Temple University Health System. “It causes no issues until it has spread somewhere. So, if it spreads to the bones, it may cause pain. If it spreads to the brain, it may cause something not subtle, like a seizure.”

WATCH: Detecting lung cancer in the absence of symptoms.

Scans such as X-rays can help detect shadows, which can prompt further testing for lung cancer. But unfortunately, lung cancer often doesn’t cause symptoms until it has already spread outside the lungs.

Some people with lung cancer may experience symptoms such as:

• A cough that doesn’t go away, gets worse, or brings up bloody phlegm
• Shortness of breath
• Fatigue
• Chest pain
• Hoarse voice
• Appetite loss
• Weight loss

If you are experiencing these kinds of symptoms consistently, contact your doctor for further tests.

There are two main types of lung cancer, which doctors group together based on how they act and how they’re treated:

• Non-small cell lung cancer (NSCLC) is the most common type and makes up about 85% of cases
• Small cell lung cancer (SCLC) is less common, but it tends to grow faster and is treated very differently

Molecular Testing & Lung Cancer Treatment

Lung cancer treatment has seen notable progress, partly because of molecular testing and profiling. This type of testing helps doctors better understand specific genetic alterations and mutations that drive the growth, development, and progression of cancer cells. Some of these molecular characteristics can be targeted using precise and effective new therapies to improve patient outcomes. Ultimately, understanding the molecular profile of each person’s cancer allows oncologists to use customized and personalized treatments.

RELATED: Next-Generation Sequencing in Lung Cancer

There are several next-generation sequencing (NGS) tests you may encounter, depending on where you are getting treatment and what you are getting treatment for.

Here are some of the common ones currently on the market:

• FoundationOne®CDx looks at 324 genes in solid tumors and results can take up to 12 days. Test results include microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions.
• OmniSeq Insight provides comprehensive genomic and immune profiling for all solid tumors. It looks for 523 different genes. Test results include microsatellite instability (MSI) and tumor mutational burden (TMB), as well as PD-L1 by immunohistochemistry (IHC).
• Cobas EGFR Mutation Test v2 identifies 42 mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor (EGFR) gene. It is designed to test tissue and plasma specimens with a single kit, allowing labs to run tissue and plasma simultaneously on the same plate.

Questions To Ask Your Doctor

• Has my cancer spread to other parts of the body?
• Based on my cancer stage, what are my treatment options?
• Have I or can I undergo genetic testing?
• Is there a targeted therapy available in my case?
• What potential side effects should I be aware of?

Contributing: SurvivorNet Staff

Learn more about SurvivorNet's rigorous medical review process.

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