Roche and Lilly to launch RET targeted cancer drugs in Korea

MFDS starts review for Roche’s ‘Gavreto’ and Lilly’s ‘Retevmo’

First indication expected to be lung cancer and thyroid cancer… competition for further indications to gain attention

Two types of RET targeted anticancer therapies are concurrently seeking domestic entry.

 

According to industry sources, Roche Korea's Gavreto (pralsetinib)’ and Lilly Korea ‘Retevmo (selpercatinib)’ are under review for domestic approval.

 

Both are anticancer drugs that target RET (Rearranged during transfection) gene fusions.

 

The drugs not only inhibit primary RET fusions and mutations but also secondary RET mutations that cause resistance to treatment, and are receiving much attention on whether they will be able to address unmet needs in various types of cancer.

 

Retevmo became the first to receive global approval by a few months.

 

Retevmo received marketing authorization from the US FDA in May last year, and Gavreto in September.

 

Retevmo was approved for the Non-small Cell Lung Cancer (NSCLC) and thyroid cancer indications, whereas Gavreto was first approved as a lung cancer treatment, then approved for the thyroid cancer indication in December of the same year.

 

Although the drugs were initially approved for lung cancer and thyroid cancer indications, the companies are expected to actively pursue more indications for RET inhibitors in the future.

 

RET gene fusions are present at a low frequency in colorectal cancer, breast cancer, pancreatic cancer, and EGFR-positive NSCLC.

 

Like NTRK (Neurotrophic tyrosine receptor kinase) targeted therapies like ‘Rozlytrek (entrectinib)’ etc., RET inhibitors have the potential to be used as tumor-agnostic, personalized treatment.

 

Meanwhile, Retevmo’s efficacy was verified through the Phase I/II LIBRETTO-001 study.

 

Retevmo’s overall response rate (ORR) was 64% in 105 RET-gene positive patients with small cell lung cancer who have previously received platinum-based chemotherapy.

 

Also, 81% of the patients who showed treatment response showed a response for at least 6 months.

 

Also, Retevmo recorded a high ORR of 84% in 39 RET-gene positive, treatment-naive patients.

 

In 143 medullary thyroid cancer patients that have previous treatment experience with ‘cabozantinib’ or ‘vandetanib,’ etc., the ORR was 69%.

 

And 76% of the patients maintained treatment response for at least 6 months.

 

In other RET-gene positive thyroid cancer, the ORR of patients with radioactive iodine-refractory (RAI) was 79%, 87% of which showed continued treatment response for over 6 months.

 

Gaverto was initially approved as a lung cancer treatment based on the ARROW study.

 

In the study, Gavreto showed an ORR of 57 % and a complete response (CR) rate of 5.7 % in NSCLC patients that were previously treated with platinum-based chemotherapy (87 patients).

 

Also, ORR was 70% and CR 11% in newly treated patients (27 patients).