First KRAS lung cancer drug Lumakras released next month

Plans to speed up the reimbursement process

Amgen holds a press conference to celebrate Lumakras’ release

Demonstrated effect by targeting KRAS G12C …well tolerated a benefit

Expectations increase on its extended use in combination with immunotherapies…tasks such as activated diagnostic testing and reimbursement remain

Non-small cell lung cancer patients with KRAS mutations are expected to be able to receive treatment with the targeted anticancer therapy ‘Lumakras (sotorasib)’ starting this August.

 

Amgen announced it will actively increase diagnostic tests and pursue reimbursement listing for the drug to increase accessibility to the only KRAS-targeted therapy in Korea.

 

On the 6th, Amgen Korea held a press conference to celebrate the launch of Lumakras in Korea at the Plaza Hotel in Jung-gu, Seoul.

 

Myung-Ju Ahn, Professor of Hematology-Oncology at Samsung Medical Center

Lumakras was approved as the first targeted anticancer therapy to target the KRAS mutation, in February this year by the Ministry of Food and Drug Safety.

 

Lumakras is indicated for use as second-line or subsequent treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.

 

Amgen succeeded in receiving FDA approval and commercializing Lumakras in only 3 and a half years after discovering the candidate substance in November 2017.

 

Lumakras binds with the P2 pocket near the KRAS G12C switch II to lock the mutated protein in an inactive state.

 

By selectively inhibiting the signaling oncogenic activity, Lumakras can prevent tumor cell growth without affecting the wild-type KRAS, Myung-Ju Ahn, Professor of Hemato-Oncology at Samsung Medical Center who attended the press conference, said, “KRAS mutations rarely occur concurrently with other common mutations in EGFR, ALK, ROS1, etc.

 

It is deeply associated with cigarette smoking, and STK-11 mutations were concurrently expressed in 1/4 of the cases.

 

Also, patients with KRAS mutations have a poorer prognosis than those without.” According to the 2-year long-term data that was presented recently, Lumakras achieved an objective response rate (ORR) of 40.7% in 174 pre-treated patients with KRAS G12C-mutated NSCLC.

 

Also, Lumakras demonstrated a median duration of response (DOR) of 12.3 months and a disease control rate (DCR) of 83.7%.

 

Results also showed a median progression-free survival (PFS) of 6.3 months and overall survival (OS) of 12.5 months with 32.5% of patients still alive at two years.

 

Lumakras is characterized by its high safety.

 

The drug specifically binds to KRAS G12C.

 

Major adverse responses found in patients in the clinical trial were mostly mild and predictable Grade 1 and 2 adverse events.

 

No new safety signals for LUMAKRAS were identified in the 2-year long-term follow-up as well.

 

On this, Professor Ahn said, “Lumakras has good tolerability as it specifically responds to G12C before differentiation without affecting wild-type KRAS.

 

81% of the patients that participated in the trial had cancers that progressed despite intensive treatment with immunotherapy or chemotherapy, and Lumakras showed an excellent therapeutic effect in these patients.” Professor Ahn also expressed high expectations on the expandability of Lumakras, which is currently used for second-line or higher treatment, as various trials on its combined use with other immunotherapy drugs are underway.

 

Ahn said, “Cancer immunotherapy drugs are currently applied reimbursement for first-line treatment of advanced NSCLC in patients with a PD-L1 expression rate of 50% or higher, but a trial on Lumakras is being conducted on its use in combination with a cancer immunotherapy drug in patients that who show poor response to immunotherapy and have negative PD-L1 expression.

 

I believe the drug will eventually become a first-line treatment in KRAS-mutated NSCLC.” In particular, 20% of patients with KRAS-mutated NSCLC concurrently express STK11 mutations, in which immunotherapy drugs show poorer effect.

 

Therefore, there are also expectations that a Lumakras+immunotherapy combo may show an effect in PD-L1 negative patients that have STK11 mutations.

 

At the conference, Amgen expressed its determination to make various efforts to increase access to Lumakras, which will be officially released at first-line hospitals in August this year.

 

The company will make efforts to list Lumakras for reimbursement and activate diagnostic tests to identify patients with KRAS mutations.

 

Miseung Kim, Senior Manager at Amgen Korea said, “We will actively engage in discussions with HCPs and health authorities in Korea to increase patient access to Lumakras by increasing diagnostic testing for KRAS mutations and receiving reimbursement, etc.”