Recently, the University of Tokyo Hospital reported a case of an 80-year-old patient with metastatic lung adenocarcinoma[1]. Initial PCR testing did not detect ALK rearrangement, but RNA sequencing revealed the presence of an EML4-ALK fusion transcript containing a premature stop codon. Although the classic fusion protein could not be translated via conventional mechanisms, IHC confirmed expression of a truncated ALK protein. After two months of treatment with alectinib, both cancerous lymphangitis and liver metastases significantly shrank, and serum tumor markers markedly decreased, demonstrating that atypical ALK fusions can still be sensitive to ALK-TKIs, offering new insights for precision therapy.

In China, lung cancer consistently ranks first in both incidence and mortality among malignant tumors, with approximately 80% of cases classified as non-small cell lung cancer (NSCLC), and 3%-7% of patients harboring ALK gene rearrangements, termed “ALK-positive NSCLC.” Unlike smoking-related lung cancers, ALK-positive patients are often younger or non-smokers, with insidious onset, rapid progression, and a high incidence of brain metastases. In advanced stages, traditional chemotherapy offers limited survival. The introduction of alectinib has dramatically changed this scenario. By precisely blocking ALK fusion protein signaling pathways, alectinib significantly prolongs survival and effectively controls intracranial metastases, advancing ALK-positive NSCLC from a “terminal disease” to a “chronic condition.”

Alectinib (No. 1256580-46-7) is a highly selective, oral ALK inhibitor that specifically targets the ALK/MEK/ERK signaling pathway, suppressing tumor cell proliferation and metastasis while sparing normal cells. Its safety profile surpasses that of traditional chemotherapy and first-generation ALK inhibitors. With strong blood–brain barrier penetration, alectinib effectively manages brain metastases, exhibits delayed resistance, and extends chemotherapy-free high-quality survival. Its broad indication covers both early-stage postoperative adjuvant therapy and advanced disease. Administered orally once or twice daily, alectinib does not require intravenous infusion, enabling most patients to maintain long-term, regular treatment and achieve “high-quality survival with tumor presence.”

Regarding safety and long-term treatment burden, a real-world study based on the Beijing Medical Insurance Database analyzed 862 ALK-positive advanced NSCLC patients. Alectinib demonstrated the longest median treatment duration (19.0 months), with lower annual total treatment costs and lower expenditures for managing adverse events compared with other ALK-TKIs. It also showed the lowest rates of treatment-related clinic visits and hospitalizations, indicating fewer and less severe side effects, thus reducing both economic and lifestyle burdens. Meta-analyses and FDA Adverse Event Reporting System data further support that alectinib carries the lowest risk of grade 3–4 adverse events, confirming its favorable safety profile.

In summary, alectinib provides ALK-positive NSCLC patients with sustained high-quality survival through precise targeting, robust efficacy, good safety, and convenient oral administration. Supported by recent clinical cases, phase III RCTs, and real-world data, it demonstrates durable efficacy, effective control of brain metastases, and a favorable safety profile, establishing itself as the first-line treatment of choice for ALK-positive NSCLC. This advances new hope for patients and promotes the precision and long-term management of ALK-positive lung cancer in China.

According to searches in the PatSnap database, alectinib is primarily protected by several core patents, with patent 4 being a divisional of patent 3. To date, the Chinese National Drug Registration Platform has not recorded any patent declarations for alectinib.

Reference:

[1] Afonso A S, Nascimento L, Cruz M, et al. (January 14, 2026) Acquired CCDC6-RET Fusion After First-Line Osimertinib in Epidermal Growth Factor Receptor (EGFR)-Mutant Lung Adenocarcinoma: A Case Report. Cureus 18(1): e101571. DOI 10.7759/cureus.101571.