ROS1-positive non-small cell lung cancer (NSCLC) | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

An aggressive type of lung cancer that typically spreads quickly is ROS1-positive lung cancer. Non-small cell lung cancer (NSCLC) cells may experience ROS1 rearrangement, a chromosomal abnormality. 1-2% of people with non-small cell lung cancer have this genetic mutation, according to statistics. It was calculated that patients with ROS1 rearrangements were on average 50.05 years old. Lung cancer generally struck people at ages 72 and older. With an incidence of 64.5%, ROS1 appears to be more prevalent in females. Two ROS1 tyrosine kinase inhibitors (TKIs) have already received first-line approval: crizotinib was approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2016 and entrectinib was approved by the FDA in 2019.

Description

Lung cancer that is ROS1-positive is a dangerous variety that frequently spreads quickly. Chromosome abnormalities, such as ROS1 rearrangement, can impact non-small cell lung cancer (NSCLC) cells. 1-2% of people with non-small cell lung cancer have this genetic mutation, according to statistics. In adenocarcinomas that lack other driver mutations, ROS1 mutations are frequently found. The most prevalent type of lymphoma, adenocarcinoma, typically begins close to the outside of the lung and usually has no symptoms in the beginning. Adenocarcinomas and ROS1 are frequently discovered at an advanced stage of cancer because these symptoms frequently do not start to manifest until the disease has spread. Protein blueprints in cells called genes control the division and growth of cells. One of these genes controls the production of an abnormal protein that then performs abnormally if it is damaged, mutated, or rearranges. One of the subfamilies of genes for insulin receptor tyrosine kinase is the ROS1 gene. The ROS1 gene mutation found in NSCLC is caused by the fusion of ROS1 with another gene. The damaged gene becomes an opportunistic element in this fusion, leading to the overgrowth of cancer cells. In 2% of patients with non-small cell lung cancer, there are genomic insertions in the ROS1 gene that are associated with a poor prognosis due to sporadic brain metastases. As opposed to being inherited or present at birth, acquired mutations, like ROS1 rearrangements, are common. ROS1 rearrangements can be found in patients with lung cancer in a number of ways. Only cancer cells have this genetic flaw; other body cells do not. Typically, tissue taken during lung cancer surgery or from lung biopsies is used for genetic testing. Liquid biopsies are being utilized more frequently by healthcare professionals to assist in the diagnosis of ROS1 rearrangements. This blood test looks for cancer cells in the blood and can be used to spot genetic changes in cancer cells.

ROS1-positive non-small cell lung cancer (NSCLC)(Epidemiology)

A 50.5-year estimate was made for the median age of patients with ROS1 rearrangements. Lung cancer was diagnosed at an average age of 72 years. According to one study, the incidence of ROS1 was 64.5%, with females appearing to have a higher incidence. Men are more likely than women to develop lung cancer. About 67.7% of the population had never smoked, which is a higher percentage. Smokers are more likely to get lung cancer overall. After breast cancer, lung cancer is the second most common cancer worldwide, and its incidence is on the rise. Lung cancer will account for 2.2 million new cases of cancer in 2020, or 11.4% of all cancer cases worldwide. In 2020, lung cancer will be blamed for the deaths of 1.8 million people. Lung cancer now accounts for the majority of cancer-related deaths worldwide, with the incidence being highest in developed nations like North America and Europe. The incidence of lung cancer differs significantly depending on the location. The highest incidence is found in Polynesia (37.3 per 100,000 people per year). West Africa has the lowest infection rate (2.2 per 100,000 people per year). Due to rising smoking rates in developing nations, especially China and India, infection rates are anticipated to rise in the upcoming years. Lung cancer trends worldwide lag smoking by decades. In many nations, including the US, Canada, the UK, and Australia, smoking rates have decreased as a result. However, despite the fact that lung cancer rates in the US are starting to level off, rates of lung cancer in women are still rising globally. Despite having much lower smoking rates than European women, Chinese women are more likely to develop lung cancer. People between the ages of 50 and 70 are most commonly affected by lung cancer. Lung cancer is very unlikely to develop in either men or women over the age of 39. After that, it started to gradually rise and peaked in people over the age of 70. All males are more susceptible to lung cancer after the age of 40. Lung cancer is more common in men than in women overall.

ROS1-positive non-small cell lung cancer (NSCLC)-Current Market Size & Forecast Trends

The market for ROS1-positive non-small cell lung cancer (NSCLC) is projected to grow significantly, with estimates indicating a value of approximately USD 3.5 billion in 2024 and expected to reach around USD 8.2 billion by 2035, reflecting a compound annual growth rate (CAGR) of about 9.5% during this period. This growth is driven by the increasing incidence of ROS1 fusions in NSCLC, which occur in about 1-2% of cases, and advancements in targeted therapies, including crizotinib, entrectinib, and repotrectinib. The introduction of new generation tyrosine kinase inhibitors (TKIs) is expected to enhance treatment options and improve patient outcomes. North America is anticipated to dominate the market due to its advanced healthcare infrastructure and ongoing research efforts, while the Asia-Pacific region is expected to show significant growth as access to these therapies improves. Overall, the ROS1-positive NSCLC market is well-positioned for substantial growth through 2035 as innovative treatments continue to emerge.

A number of ROS1 tyrosine kinase inhibitors (TKIs) have been created, and two of them have already received first-line approval: crizotinib was approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2016 and entrectinib was approved by the FDA in 2019. Treatment with ROS1 TKIs significantly increased overall survival (OS) in patients with ROS1-positive NSCLC, and ROS1 TKIs also helped patients achieve higher response rates (RR) and progression-free survival (PFS) compared to those who did not receive treatment. Pemetrexed, an alchemist of platinum. In the PROFILE 1001 study, 53 patients with advanced ROS1-positive TKI-nave NSCLC received crizotinib, a multitargeted TKI targeting ALK, ROS1, and MET. Crizotinib had a RR of 72%, a median PFS of 19point 3 months, a median OS of 51point 4 months, and a 4-year OS of 51% after a median follow-up of 46point 2 months. There was no grade 4 or grade 5 TREs or TRAE-related discontinuations, and the rate of grade 3 treatment-related adverse events (TRAEs) was 36%. For patients with ROS1-positive and ALK-positive NSCLC, individualized TKI therapy can significantly enhance patient outcomes. Crizotinib remains the best first-line treatment option for patients with ROS1-positive NSCLC, followed by next-generation TKIs at disease progression, despite the fact that it has long been the preferred standard of care for patients with remodeling NSCLC. Next-generation TKIs, on the other hand, have improved intracranial efficacy, making them first-line treatments for these patients. As all patients experience disease progression while receiving TKI therapy, it is essential to comprehend the mechanisms of acquired resistance in order to choose the best sequential therapy approach. Although personalized therapy is associated with better patient outcomes, access to next-generation TKIs and genotyping as the disease progresses present significant obstacles to achieving this goal. In TKI-nave and crizotinib-resistant NSCLC patients with ROS1-positive tumors, lorlatinib and repotrectinib significantly outperformed other TKIs in terms of ICRR activity. After crizotinib treatment, individualized therapy is required, especially if lorlatinib is an available treatment option. Genomic testing to rule out the G2033R mutation is required. The best prognosis for patients with ROS1-positive NSCLC may depend on safety, intracranial activity, and possible future treatments at progression. Alectinib, the current first-line medication for advanced ALK-remodeling NSCLC, exhibits the best combination of clinical activity and safety. Patients with metastatic NSCLC who have progressed to a second-generation ALK TKI and have an ALK-rearranged gene are eligible for lorlatinib. The identification of genome-guided therapeutic sequences may be aided by molecular profiling of second-generation ALK TKIs during the course of the disease. As an alternative, non-invasive method to identify ROS1 or ALK resistance mutations during TKI therapy and direct treatment approaches throughout the disease process, plasma genotyping is becoming more and more popular. Only after effective targeted therapy and chemotherapy have been exhausted should univariate ICI be taken into consideration in ROS1/ALK-positive NSCLC.

Report Highlights

ROS1-positive non-small cell lung cancer (NSCLC)- Current Market Trends

ROS1-positive non-small cell lung cancer (NSCLC)- Current & Forecasted Cases across the G8 Countries

ROS1-positive non-small cell lung cancer (NSCLC)- Market Opportunities and Sales Potential for Agents

ROS1-positive non-small cell lung cancer (NSCLC)- Patient-based Market Forecast to 2035

ROS1-positive non-small cell lung cancer (NSCLC)- Untapped Business Opportunities

ROS1-positive non-small cell lung cancer (NSCLC)- Product Positioning Vis-a-vis Competitors' Products

ROS1-positive non-small cell lung cancer (NSCLC)- KOLs Insight