培美替尼治疗胆管癌的试验数据?

This study evaluated the antitumor activity and safety of pemetinib in Chinese patients with previously treated advanced cholangiocarcinoma and fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements. It has brought clinical benefits to patients with previously treated cholangiocarcinoma carrying FGFR2 fusions or rearrangements, and has been approved for this indication in many countries.

research methods

In this ongoing multicenter, single-arm, phase II study (NCT04256980), adult patients with locally advanced or metastatic cholangiocarcinoma with a centrally confirmed FGFR2 fusion or rearrangement and disease progression after receiving ≥1 systemic therapy received oral pemetinib 13.5 mg once daily (3-week cycle; 2 weeks on, 1 week off) until disease progression, unacceptable toxicity, or consent to discontinuation. The primary endpoint was objective response rate (ORR), as assessed by an independent radiology review committee.

Test results

Median follow-up was 5.1 months (1.5-9.3 months). Among the 30 patients with FGFR2 fusion or rearrangement who underwent efficacy evaluation, 15 patients achieved partial response (ORR, 50.0%); 15 patients had stable disease, and the disease control rate was 100%. The median time to response was 1.4 months, the median duration of response was not reached, and the median progression-free survival was 6.3 months.

Eight of 31 patients (25.8%) experienced grade ≥3 treatment flares. Hyperphosphatemia, hypophosphatemia, nail toxicity, and eye disease were mostly less than grade 3, and only 2 cases were grade ≥3.

Test conclusion

The encouraging antitumor activity and favorable safety profile support the use of pemetinib in the treatment of previously treated Chinese patients with cholangiocarcinoma and FGFR2 rearrangements.

Pemetinib’s effects

Pemetinib is a small molecule kinase inhibitor targeting FGFR. It is an oral drug that works by specifically binding to the tyrosine kinase (TK) of tumor cells. It is suitable for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. Pemetinib has shown strong efficacy and good safety in the treatment of FGFR fusion/rearrangement and mutant malignant tumors. It can prevent the growth and spread of tumor cells by blocking FGFR2 in tumor cells, bringing hope to patients to extend their survival and improve their quality of life.

Pemetinib usage and dosage

Pemetinib is administered orally at 13.5 mg daily for 14 days, followed by 7 days off in a 21-day cycle. Continue treatment until disease progression or unacceptable toxicity. Swallow the pemetinib tablet whole, with or without food.

pemetinib price

Pemetinib was approved for marketing in China in April 2022. Patients can purchase it at domestic hospital pharmacies. However, due to different conditions and environments in various regions, the price will also vary. Patients in need can consult local hospital pharmacy personnel for specific prices.

Through domestic professional overseas medical service organizations (such as Medical Companion Travel), we learned that the price of the Lucius version of pemetinib in Laos, 4.5 mg x 14 tablets, is about $900 per box, but the price is not fixed due to various factors.

Patients can also obtain it through domestic professional overseas medical service organizations (such as Medical Companion Travel). The drugs can be mailed to their homes, which is more cost-effective and the drug purchase is guaranteed. It is recommended to consult the customer service personnel for specific costs and acquisition procedures.

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References

Shi GM, Huang XY, Wen TF, Song TQ, Kuang M, Mou HB, Bao LQ, Zhao HT, Zhao H, Feng XL, Zhang BX, Peng T, Zhang YB, Li XC, Yu HS, Cao Y, Liu LX, Zhang T, Wang WL, Ran JH, Liu YB, Gong W, Chen MX, Cao L, Luo Y, Wang Y, Zhou H, Yang GH, Fan J, Zhou J. Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study. Cancer Med. 2023 Feb;12(4):4137-4146. doi: 10.1002/cam4.5273. Epub 2022 Sep 20. PMID: 36127767; PMCID: PMC9972033.