HTR2B as a novel biomarker of chronic obstructive pulmonary disease with lung squamous cell carcinoma

Tiragolumab Plus Tecentriq Misses Survival Endpoint For Lung Cancer Subset

The primary endpoint of overall survival was missed in the SKYSCRAPER-01 study assessing tiragolumab plus Tecentriq in some patients with non-small cell lung cancer.

Genentech announced that a clinical trial of tiragolumab plus Tecentriq did not meet its primary endpoint of overall survival in patients with non-small cell lung cancer.

The primary endpoint of overall survival was not met in the phase 3 SKYSCRAPER-01 study comparing tiragolumab plus Tecentriq (atezolizumab) with Tecentriq alone to treat PD-L1-high, locally advanced or metastatic non-small cell lung cancer.

The announcement was made in a press release from Genentech, the manufacturer of tiragolumab. Tiragolumab, according to the release, is an immune checkpoint inhibitor that selectively binds to TIGIT, a novel inhibitory immune checkpoint that may suppress the immune response to cancer.

Of note, when a primary endpoint is not met in a clinical trial, it means that the treatment that was tested did not meet the specific goal set by researchers for that trial.

"Genentech continuously reviews its study programs to determine if any adjustments are necessary for the purposes of ongoing research," as noted in the release. "Genentech will apply the same principles to this program, with additional data from phase 3 studies across different settings or tumor types anticipated next year."

Glossary:

PD-L1: a protein that serves as a brake to keep the body's immune responses under control. There may be higher counts of this protein on some types of cancer cells.

Overall survival: the time when a patient with cancer is still alive.

Immune checkpoint inhibitor: a drug that blocks checkpoints, a type of protein created by immune system cells like T cells and some cancer cells. Blocking these checkpoints can help T cells improve their ability to kill cancer cells.

Progression-free survival: the time from treatment assignment to the first occurrence of disease progression or all-cause death.

Objective response rate: the percentage of patients who had a complete or partial response to treatment.

Duration of response: how long a patient's disease responds to treatment, or the time period between when the cancer starts to shrink or disappear and when it starts to grow again.

In addition to the study not meeting its primary endpoint of overall survival, the overall safety profile of the treatment was consistent with that observed in longer follow-up with no new safety signals, as noted in the release.

Findings from this study will be presented at an oncology conference in 2025, Genentech mentioned.

The SKYSCRAPER-01 included 534 patients with PD-L1-high, previously untreated, locally advanced unrespectable or metastatic non-small cell lung cancer, according to the release. The ClinicalTrials.Gov listing for the study noted that the exact patient population included those with non-small cell lung cancer previously treated with two or more cycles of concurrent platinum-based chemoradiotherapy and did not experience radiographic disease progression.

Patients were randomly assigned to receive either tiragolumab plus Tecentriq or Tecentriq alone. According to the ClinicalTrials.Gov listing, Tecentriq was given intravenously every four weeks, whereas tiragolumab was given intravenously on day 1 of each 28-day cycle. Treatment was administered until loss of clinical benefit, disease progression or unacceptable toxicity.

Roche, who partners with Genentech, shared preliminary findings from the SKYSCRAPER-01 study in August 2023. In particular, the overall survival estimates were 22.9 months for patients assigned tiragolumab plus Tecentriq compared with 16.7 months in those assigned Tecentriq monotherapy, which was not statistically significant.

According to the study's ClinicalTrials.Gov listing, researchers were focusing on other areas of interest including progression-free survival, objective response rate, duration of response and several quality-of-life measures.

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Lee Health: It's Lung Cancer Awareness Month

Lung cancer is the third most common type of cancer diagnosed in the United States but is the deadliest cancer in our country. The Centers for Disease Control and Prevention (CDC) reports that more Americans die from lung cancer than any other type of cancer. Cigarette smoking is the number one risk factor for lung cancer. Secondhand smoke, family history, lifestyle choices (poor diet and lack of exercise) and occupational exposures to materials like asbestos can also contribute to the disease. For those without a smoking history, radon exposure is the highest risk factor for lung cancer.

As with other cancers and health conditions, early detection means more opportunities to take advantage of the most comprehensive treatment options. The only recommended screening for lung cancer is a low-dose CT scan, which involves lying still on a table and slowly moving through the scanner. There's no IV or medications. The entire process takes less than 10 minutes, and the radiation exposure through this scan is more than a regular X-ray but less than 10% of a regular CT scan. The low-dose CT scan finds small nodules or other abnormalities in the lungs.

To be eligible for the lung cancer screening, you must meet the criteria:

You are 50-80 years of age.

You currently smoke, or you quit in the past 15 years.

You have at least a 20-pack-a-year smoking history.*

You do not have signs or symptoms of lung cancer (chest pain, strong cough, trouble swallowing, wheezing, shortness of breath or coughing up blood).

* This is the number of years smoked multiplied by the number of packs of daily cigarettes. For example: 1 pack/day X 20 years = 20 packs-a-year.

If you believe you meet the criteria, a prescreening is required.

Bobbi Marino, MSN, APRN, TTS, FNP-BC, OCN, Lee Health Cancer Institute Lung Cancer Screening Program director, explains the process. "You can ask your primary care provider for a referral to the Lung Cancer Screening Clinic, or you can go to LeeHealth.Org/Lung-Cancer-Screening and complete the 'Schedule a Screening' questionnaire on the right-hand side of the webpage," she said.

"Once you complete and submit the prescreening form, the clinic will receive the information and contact you for a visit to complete a health history and discuss lung cancer screening — this can be an in-person appointment or via a virtual visit. Once we confirm you meet the lung cancer screening criteria, I will place an order for the low-dose CT, and we can schedule it, working with your schedule and preferred location."

Lung cancer screening is covered 100% by Medicare, Medicaid and most insurance plans. Financial assistance is available for those who are uninsured and underinsured.

"If an abnormality is detected, it does not mean you have lung cancer," Bobbi said. "Our lung cancer screening often uncovers chronic obstructive pulmonary disease (COPD), coronary artery calcification, aortic aneurysm or other conditions. If an abnormality is suspicious for lung cancer, then our team—in collaboration with your primary care physician—will direct you into our lung nodule pathway for additional evaluation to determine a diagnosis and personalized treatment plan that is best for you."

For more information about lung cancer and screening, visit LeeHealth.Org and search for "Lung cancer."

Larry Antonucci, M.D., MBA is the president & CEO of Lee Health, Southwest Florida's major destination for health care offering acute care, emergency care, rehabilitation and diagnostic services, health and wellness education, and community outreach and advocacy programs. Visit LeeHealth.Org to learn more.

More: Lee Health: Help us rename Challenger Boulevard

And: Lee Health: Celebrating our transition to a community-focused nonprofit system

Also: Lee Health: Education, support for living well with Parkinson's

This article originally appeared on Naples Daily News: Lee Health: It's Lung Cancer Awareness Month

Experts Link Lung Cancer Risks To Air Pollution, Passive Smoking

Lung cancer leads to global cancer-related mortality rates, affecting both men and women. The World Health Organisation attributes 85% of cases to tobacco use and air pollution, highlighting these as the primary risk factors.

In 2022 alone, 20 million new cancer cases were reported globally, with 9.7 million deaths—one in five individuals develop cancer during their lifetime, with mortality rates of one in nine for men and one in 12 for women.

Read Also: Why lung cancer cases are rising among women and youth

To gain insights into lung cancer detection, management and treatment, we spoke with leading oncologists: Dr Ankur Bahl, Senior Director of Medical Oncology at Fortis Memorial Research Institute; Dr Devavrat Arya, Oncologist at Max Hospital Saket; Dr Sajjan Rajpurohit, Senior Director of Medical Oncology at BLK-Max Super Speciality Hospital; and Dr Pooja Babbar, Consultant of Medical Oncology at C K Birla Hospital.

Excerpts

Air pollution increases lung cancer risk

Dr Bahl: A study by The Lancet found that air pollution causes 1.67 million deaths in India every year, including cancer-related deaths. Exposure to fine particulate matter (PM2.5), industrial emissions, vehicular exhaust, and other pollutants can lead to chronic inflammation and oxidative stress, increasing lung cancer risk. Recent studies have shown that long-term exposure to high levels of air pollution can be as detrimental as smoking in terms of lung cancer risk. The alarming rise in air pollution levels, particularly in urban areas highlights the need for stricter environmental regulations and collective efforts to minimise exposure such as using air purifiers and wearing protective masks.

Passive smoking and cancer link

Dr Arya: Second-hand smoke (SHS) is a serious but often underestimated threat to non-smokers, playing a critical role in lung cancer development. Exposure of non-smokers to dangerous chemicals through second-hand smoke, which includes carcinogens, can result in lung cancer. Research suggests that there is a 25-30% increased risk of lung cancer due to second-hand smoke exposure. Also, according to the Indian Council of Medical Research (ICMR), approximately 1 million Indians die each year due to smoking-related diseases, while the impact of second-hand smoke exposure on non-smokers cannot go unnoticed.  It is also important to note that vulnerable groups, including children and pregnant women, face heightened risks.

Role of lifestyle changes in reducing lung cancer risk

Dr Ankur Bahl: Reducing the risk of lung cancer involves a combination of lifestyle changes, regular health check-ups and awareness. Here are some adjustments that can help lower your risk:

Quit smoking: The most effective way to reduce lung cancer risk is to quit smoking and avoid exposure to tobacco smoke.

Healthy diet: A diet rich in fruits, vegetables, and whole grains, while low in processed foods and red meat, can support overall lung health.

Regular exercise: Engaging in moderate physical activity can strengthen your immune system and improve lung function.

Limit exposure to pollutants: Minimize exposure to air pollution and occupational hazards (like asbestos) by using protective gear and ensuring proper ventilation.

Avoid radon: Test your home for radon levels, especially if you live in an area known for high radon emissions, as it's a leading cause of lung cancer after smoking.

Steps to lower your risk of lung cancer

Dr Babbar: To lower your risk of lung cancer, consider these proactive steps: Quit smoking and avoid second-hand smoke, as these are the primary risk factors. Maintain a healthy diet rich in fruits, vegetables, and whole grains. Engage in regular physical activity to boost overall health. Minimise exposure to air pollution and radon gas. If you have a family history of lung cancer or are a heavy smoker, consult your doctor about screening options like low-dose CT scans.

Small cell and non-small cell lung cancer

Dr Rajpurohit: Lung cancer is generally divided into two main types: small-cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). These two types differ significantly in terms of their growth patterns, treatment, and outcomes.

Small cell lung cancer (SCLC) accounts for about 15% of lung cancers and tends to grow and spread very quickly. This cancer type is often linked to smoking and is typically more aggressive, meaning it spreads to other parts of the body faster. Due to its rapid growth, SCLC is usually treated with chemotherapy and, sometimes, radiation to control its spread. Surgery is less common because the cancer often spreads before it's detected.

Non-small cell lung cancer (NSCLC), on the other hand, makes up about 85% of lung cancer cases. This group includes subtypes like adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC grows more slowly than SCLC, so if detected early, it may be treated with surgery, chemotherapy, radiation, and newer targeted therapies or immunotherapy.

Modern technologies of lung cancer diagnosis and treatment

Dr Bahl: Advancements in medical technology have significantly improved the diagnosis and treatment of lung cancer. Some of the modern diagnostic tools include:

Low-dose CT scans: These are more effective than standard X-rays for detecting early-stage lung cancer, especially in high-risk individuals.

PET-CT scans: These provide detailed images that help determine the extent of cancer and guide treatment planning.

Biomarker testing and liquid biopsies: These can identify genetic mutations and other biomarkers, allowing for personalized treatment plans.

For treatment, modern options include:

Targeted therapy: Drugs that target specific genetic mutations in cancer cells.

Immunotherapy: Treatments that boost the body's immune system to fight cancer.

Robotic-assisted surgery: Minimally invasive procedures that reduce recovery time and improve outcomes.

Radiotherapy with stereotactic techniques: Highly focused radiation treatments that minimise damage to surrounding tissues.

Read Also: World's First Lung Cancer Vaccine Trial Begins

Signs and symptoms of lung cancer

Dr Babbar: Early signs of lung cancer can be subtle and often mistaken for other illnesses. Common symptoms include a persistent cough that worsens or doesn't go away, coughing up blood, chest pain, shortness of breath, hoarseness, and unexplained weight loss or fatigue.

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