Breakthrough Clinical Results
HUTCHMED announced that the China National Medical Products Administration (NMPA) approved the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for treating locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR tyrosine kinase inhibitor (TKI) therapy. This approval is based on data from the Phase III SACHI trial (NCT05015608), which showed a 66% reduced risk of progression or death compared to platinum-based chemotherapy. The combination offers an all-oral, chemotherapy-free approach for patients who develop MET amplification after progressing on EGFR inhibitors. This approval triggers an $11 million milestone payment from AstraZeneca, which markets both drugs in China. The safety profile of the combination was considered tolerable.
Key Highlights
- China NMPA approves ORPATHYS® and TAGRISSO® combination for lung cancer.
- Phase III SACHI trial demonstrated a 66% reduced risk of progression or death compared to chemotherapy.
- All-oral, chemotherapy-free treatment option for MET-amplified NSCLC patients.
- $11 million milestone payment triggered from AstraZeneca.
Incidence and Prevalence
Global Epidemiology of Lung Cancer
Incidence and Prevalence
Lung cancer has become the most prevalent neoplasm throughout the world with 1.2 million deaths per year. It remains one of the leading causes of cancer mortality worldwide. The global lung cancer incidence was reported to be much lower among females vs males (13.6 vs 34.2 per 100,000).
A revised estimate of global lung cancer incidence in 2012 was 23.6 compared to the Globocan 2012 estimate of 23.1, amounting to approximately 38,101 missed cases (95% confidence interval: 28,489-47,713).
Regional Variations
Distinct spatial heterogeneity was observed for incident lung cancer, which appeared concentrated in contiguous regions. The largest relative under-estimation was predicted for Africa, Central America and the Indian Ocean regions (Comoros, Madagascar, Mauritius, Mayotte, Reunion, Seychelles).
In Central and Eastern European (CEE) countries, a study examining data from 1960-1989 found that among males, recent lung cancer death rates were the highest in Europe. For females, lung cancer mortality rates were much lower, although there were exponential rate increases.
A specific regional study in Dafeng City, Jiangsu Province, over 9 years (1999-2007), showed the crude incidence of cancers was 244.99 persons per 100 thousand and the standard incidence ratio (SIR) was 175.48 persons per 100 thousand. The crude incidence and SIR of cancers of males was 299.22 persons per 100 thousand and 214.41 persons per 100 thousand respectively, 1.57 and 1.76 times as high as those of females (190.92 per 100 thousand and 137.34 per 100 thousand respectively).
Types and Mutations
Non-small cell lung cancer (NSCLC) is the second most common cancer globally. In a study of 224 patients with lung cancer, adenocarcinoma was the most common type (70%), followed by squamous cell carcinoma (24%), while large cell lung cancer was noted in only 3% of patients.
The most common mutations in lung cancer patients were EGFR mutations (15%), followed by PD-L1 expression (24.7%), KRAS (8.3%), ALK1 (4.2%), BRAF (1.6%), ROS1 (1%), and MET (0.5%).
Trends and Factors
The incidence and mortality of lung cancer have increased per year in many countries over the past 50 years. In the more recent birth cohorts, there were some declines in mortality rates among males, but not among females.
The increasing cigarette consumption through the 1960s, 1970s, and 1980s is accompanied in most countries by rising lung cancer mortality rates for young adults. This increasing cigarette consumption will determine future trends in lung cancer, which will increase well beyond the turn of the century and will continue longer for females than for males.
A study in EU countries (n=28) identified the most important factors for lung cancer mortality for both genders as the incidence of lung cancer, the price of tobacco, and the number of doctors per 100,000 inhabitants.
The pathogenesis of lung cancer is extremely complicated and includes genetic factors, living environment, and smoking, and is related to the regulation of many oncogenes and tumor suppressor genes.
Drug used in other indications
ORPATHYS® and TAGRISSO® Indications Beyond Lung Cancer
Based on the available information, there is no specific information about ORPATHYS® (savolitinib) or TAGRISSO® (osimertinib) being trialed for indications other than lung cancer. The current data only confirms these medications are used for lung cancer treatment, but does not mention any other conditions they might be investigated for.
Similarly, there is no information available regarding intervention models for trials in other conditions for these medications.
Company drugs in pipeline
I notice that the provided context contains only placeholder text with "NA" values and doesn't contain any actual information about HUTCHMED's drug pipeline or indications. Without specific information in the context about HUTCHMED's clinical development pipeline, therapeutic indications, disease targets, oncological conditions, immunological conditions, or other medical conditions they are developing drugs for, I cannot provide a comprehensive answer to these queries.
To properly answer these questions, I would need context containing specific information about HUTCHMED's drug development programs, clinical trials, and target indications.