Two innovative drugs for lung cancer are expected to be a new first-line therapy

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Two innovative drugs for lung cancer have good curative effect and are expected to be a new first-line therapy

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WCLC Highlights: Two innovative drugs for lung cancer have good curative effect and are expected to be a new first-line therapy.

The annual World Conference on Lung Cancer (WCLC) is set to take place from September 9 to 12 in Singapore.

As a premier international academic conference in the field of global lung cancer, WCLC has always been a significant platform for the release of important clinical research findings.

Currently, most of the research abstracts scheduled for presentation at this year’s WCLC have been unveiled. Here, we will provide a preliminary overview of two crucial developments in targeted therapy for non-small cell lung cancer (NSCLC).

Novel ROS1 Inhibitor Continues to Shine, Achieving Nearly 3-Year Median PFS in First-Line Treatment!

Repotrectinib (informally  with research code TPX-0005 serves as a new-generation tyrosine kinase inhibitor (TKI) targeting ROS1 mutations.

It boasts an impressive preliminary objective response rate (ORR) of 93% for treatment-naive patients, positioning itself as a highly anticipated star in targeted therapy.

This year’s WCLC featured the release of updated efficacy and safety data from the clinical phase I/II TRIDENT-1 study of Repotrectinib for both treatment-naive (n=71) and previously TKI-treated (n=56, with patients having no prior chemotherapy history) NSCLC patients (with a minimum follow-up of 14 months)[1].

The data reveals an ORR of 79% for treatment-naive patients and 38% for TKI-treated patients.

However, the most remarkable efficacy data is undoubtedly the median progression-free survival (PFS) of a staggering 35.7 months for treatment-naive patients.

Simultaneously, the median duration of response (DoR) for responding patients also reaches 34.1 months.

For patients with measurable baseline intracranial metastases, the intracranial response rates with Repotrectinib are 89% for treatment-naive patients and 38% for previously treated patients.

The safety data presented in this report include 426 patients treated with the recommended phase II dose (RP2D, with a specific regimen of Repotrectinib at 160mg QD for 14 days, followed by a change in dosing frequency to BID).

The most common treatment-emergent adverse events (TEAEs) are dizziness, with a 51% incidence of ≥3-grade TEAEs (n=216), and 29% of these were attributed to the treatment.

Rates of dose reduction and permanent discontinuation due to TEAEs were 38% and 7%, respectively.

These efficacy and safety data once again demonstrate that Repotrectinib, when used in treatment-naive or previously treated patients with ROS1 mutations, exhibits durable and substantial antitumor activity, with excellent intracranial and extracranial efficacy, and overall manageable safety.

First-Line Treatment Takes the Lead! MET Inhibitor Savolitinib Achieves Key Success in Phase III Clinical Study

MET exon 14 skipping mutations (MET ex14+) have recently gained significant attention in the realm of targeted therapy for NSCLC.

Savolitinib, the first MET-TKI approved in China, is an innovative drug developed domestically.

Professor Shun Lu from Shanghai Jiao Tong University School of Medicine will be presenting the primary results of the phase IIIb clinical study of Savolitinib in treatment-naive patients with MET ex14+ advanced NSCLC at this year’s WCLC[2].

According to the disclosed research abstracts, the study’s first-line treatment cohort (cohort 2) enrolled a total of 87 locally advanced or metastatic treatment-naive patients with MET ex14+ NSCLC.

The median age of these patients was 70 years, with nearly 90% having adenocarcinoma or sarcomatoid carcinoma, the majority at stage IV, and an ECOG PS score of 1.

The median duration of Savolitinib treatment exceeded 8 months.

Among the 84 patients who underwent at least one tumor assessment after treatment, the independent review committee (IRC) assessed an ORR of 59.5% (50/84, all partial responses) for Savolitinib treatment and a disease control rate (DCR) of 95.2%.

In the entire cohort of 87 patients, the median DoR for Savolitinib treatment has not been reached.

The median time to response (TTR) from the start of treatment was 1.4 months, with a median PFS of 12.6 months (95% CI: 8.5 – , median follow-up time for PFS 8.3 months).

The 6-month and 12-month PFS rates were 76.2% and 61.0%, respectively, and the median overall survival (OS) has not been reached.

The incidence of ≥3-grade TEAEs with Savolitinib treatment was 77.0%, and the incidence of ≥3-grade treatment-related adverse events (TRAEs) was 66.7%. The most common TRAEs included abnormal liver function (21.8%), hypokalemia (5.7%), and peripheral edema (5.7%).

In summary, the efficacy of first-line Savolitinib treatment is substantial, and its safety profile is generally similar to the earlier phase II registration study.

It is poised to become a preferred first-line treatment option for patients with MET ex14+ advanced NSCLC.

Two innovative drugs for lung cancer have good curative effect and are expected to be a new first-line therapy

(source:internet, reference only)

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