Keytruda's indication expanded for early-stage lung cancer

Now holds 25 indications

Keytruda received MFDS approval as pre- and post-operative adjuvant therapy on 19th

In addition to Tagrssio and Alecensa, Keytruda can be used in early-stage lung cancer patients.

Reimbursement process has stalled.

MSD’s immuno-oncology drug Keytruda has been approved for early-stage lung cancer, totaling its indication count to 25.

 

With the latest approval, Keytruda became the third treatment, alongside AstraZeneca’s Tagrisso and Roche’s Alecensa, that can be used as neoadjuvant and adjuvant therapy.

 

With major lung cancer treatment now approved for early-stage treatments, this approval enhances preventive measures against metastasis and recurrence.

 

According to the pharmaceutical industry, on 23rd, Ministry of Food and Drug Safety (MFDS) approved an expanded indication for Keytruda (pembrolizumab), a PD-1 inhibitor class anticancer immunotherapy.

 

Previously, on the 19th, Keytruda had received approval for two indications as a combination with platinum-based chemotherapy for pre-surgical neoadjuvant therapy, and as a monotherapy for the adjuvant therapy following surgical resection in patients with non-small cell lung cancer (NSCLC).

 

MSD Korea

Keytruda has become the first anti-cancer immunotherapy to receive approval for both pre- and post-operative adjuvant therapy in early-stage-lung cancer.

 

Including targeted therapies, Keytruda became the third treatment, alongside AstraZeneca’s Tagrisso (osimertinib), which targets EGFR mutation, and Roche’s Alecensa (alectinib), which targets ALK mutation, to be approved.

 

The current expanded indications for Keytruda were based on results from the Phase 3 KEYNOTE-811 clinical trial, which compared trastuzumab plus fluoropyrimidine and chemotherapy against trastuzumab plus chemotherapy.

 

Findings from 28.3 months follow-up of NSCLC indicated that patients with PD-L1(CPS≥1) in Keytruda combination therapy group experienced a median progression-free survival (PFS) of 10.8 months.

 

This was longer compared to the 7.2 months PFS observed in trastuzumab plus chemotherapy group.

 

Keytruda’s effectiveness was also confirmed in the Phase 3 KEYNOTE-671 clinical trial, which evaluated Keytruda as neoadjuvant and adjuvant therapy regimen for patients with stage 2, stage 3A, or stage 3B NSCLC.

 

The trial enrolled 797 patients with stage 2, stage3A-B NSCLC.

 

The effectiveness and safety of Keytruda were evaluated in patients who were randomized (1:1) to either Keytruda or placebo following adjuvant cisplantin-based chemotherapy for 4 cycles, and were treated up to 13 cycles.

 

In the trial, the primary endpoints included event-free survival (EFS) and overall survival (OS).

 

Secondary endpoints included pathological responses, pathological complete response (CR), and safety.

 

During a 25.2-month follow-up of patients, the study found that the 24-month EFS rate was 62.4% in the Keytruda group compared to 40.6% in the placebo group.

 

While the OS rate for the Keytruda group was significantly higher than the control group, median values were not reached.

 

Pathological CR, a secondary endpoint, was observed in 30.2% of patients in the Keytruda group and 11.0% in the placebo group.

 

The researchers concluded that, “the inclusion of Keytruda after adjuvant platinum-based chemotherapy notably improved the pathological CR in patients with resectable early-stage NSCLC.” Keytruda’s indications are expanding, but few of those indications received a notice for re-evaluation at the Cancer Disease Review Committee. On the 19th, Keytruda has been approved for a first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive gastric cancer.

 

According to the approval, Keytruda is indicated for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1), and to be used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

 

There is a need for new treatments for HER2-positive gastric cancer, as there have been no new treatment options since combination therapy of trastuzumab plus chemotherapy was approved in 2010.

 

Likewise, Keyruda is expanding its range of applications, yet discussion for its reimbursement are still ongoing.

 

Moreover, in June, Keytruda submitted a request for expanded reimbursement for 13 indications, including those for non-small cell lung cancer (NSCLC), head and neck cancer, esophageal cancer, urothelial carcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, triple-negative breast cancer, cervical cancer, and etc.

 

The majority of indications have not cleared the hurdle of the Cancer Disease Review Committee.

 

Four indications, including those for head and neck cancer, endometrial cancer, urothelial carcinoma, and triple-negative breast cancer, were submitted to the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee, but they have received a notice for re-evaluation.

 

After receiving the re-evaluation notice in October including esophageal cancer, endometrial cancer, pancreatic cancer, and colorectal cancer, a total of seven indications of Keytruda have yet to receive approval by the Cancer Disease Review Committee.