Roche joins in competition for RET-targeted therapies

Following Lilly.. heats up market competition

Roche receives approval for Gavreto 18 days after Lilly’s Retevmo receives approval

Shows difference in scope of indication and method of administration… hurries to preoccupy market

Following Lilly, Roche has also received approval for its RET targeted anticancer therapy.

 

The entrance of two drugs in a similar period is expected to spark new competition in the RET-targeted therapy market.

 

On the 29th, Roche received marketing authorization for ‘Gavreto (pralsetinib) from the Ministry of Food and Drug Safety.

 

Its first indications are for non-small cell lung cancer and thyroid cancer.

 

More specifically, Gavreto was approved for the treatment of adult patients with RET fusion-positive locally advanced or metastatic NSCLC, and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy.

 

Gavreto is the second RET-targeted therapy to be introduced to Korea following Retevmo.

 

Retevmo (selpercatinib), which was developed by Lilly, received MFDS approval on the 11th.

 

The two drugs have virtually landed at the same time in Korea.

 

By indication, Retevmo’s indication is a bit broader.

 

Compared to Gavreto, whose prescription was limited to adult patients, Retevmo may be used in patients over 12 years of age with medullary thyroid cancer.

 

Also, Retevmo has an additional indication for RET fusion-positive thyroid cancer.

 

The two drugs also show a difference in their form of administration.

 

Retevmo is taken orally two times a day and may be taken with or without food as long as it is not co-administered with PPIs.

 

If the drug needs to be taken with antacids such as PPI or H2 receptor antagonists, Retevmo should be taken after a certain period.

 

On the other hand, Gavreto can be taken orally only once a day.

 

However, food intake is prohibited 2 hours before administration and at least an hour after administration.

 

In the LIBRETTO-001 that was the basis of Retevmo’s approval, the ORR of the Retevmo-treated group in patients with RET fusion-positive NSCLC without platinum-based treatment experience was 85%, and 79% showed a continued response.

 

In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.

 

10 of the 11 patients had shown objective CNS response for the brain metastasis that around half of the patients experience.

 

Major adverse events included increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased blood sugar (glucose), decreased leukocytes, decreased albumin, and high blood pressure.

 

In patients with medullary thyroid cancer, the treatment-naïve patients showed a response rate of 73%, and those with experience 69%.

 

The response rate of Retevmo in RET fusion-positive thyroid cancer was 79%.

 

In the ARROW trial, which became the basis of Gavreto’s approval, Gavreto showed an ORR of 70% in treatment-naïve NSCLC patients.

 

Patients who have been previously treated with platinum-based chemotherapy and those who received systemic therapy showed a 58% response.

 

In RET-mutated locally advanced or metastatic medullary thyroid cancer, treatment-naïve patients recorded a response rate of 71%, and those with experience 60%.

 

The major adverse events reported included neutropenia, anemia, and high blood pressure.

 

Until now, only chemotherapy was available as an option for cancer patients with RET gene mutations.

 

The introduction of Retevmo and Gavreto in the area is expected to dramatically improve the treatment environment.

 

The scope of application of the drug is also wide.

 

Oncogenic RET gene mutation is found not just in non-small cell lung cancer and thyroid cancer, but also in colorectal cancer, breast cancer, and pancreatic cancer.

 

With the two drugs entering in a similar timeframe, the companies are expected to race to occupy a larger share of the pie.

 

Lilly, which first received approval, has been showing more progress.

 

The company has applied for Retevmo’s reimbursement through the approval-reimbursement linkage system.

 

Lilly is also conducting a Phase III trial on patients with early-stage NSCLC for the use of Retevmo as adjuvant therapy after curative treatment (surgery or radiotherapy).