Keytruda indication has been expanded

New Options for Proactive Cancer Therapy

Obtain adjuvant therapy indications before and after surgery in phase 2 to 3

The immuno-cancer drug Keytruda has expanded its treatment indication to early triple negative breast cancer following metastaticity.

 

With the addition of Keytruda to adjuvant therapy before and after surgery, it is expected to contribute to reducing the recurrence rate by using immuno-cancer drugs early.

 

MSD Korea held a press conference at the Bank Hall in Jung-gu, Seoul on the 22nd and highlighted the meaning of Keytruda's approval of adjuvant therapy before and after early triple negative breast cancer surgery.

 

Keytruda expanded its scope to supplementary therapy before and after surgery for early triple negative breast cancer a year after obtaining indications for the first treatment of recurrent and metastatic triple negative breast cancer in July last year.

 

It can be used as a kitruda-antio-cancer chemotherapy (Carboplatin+Paclitaxel, Doxorubicin or Epirubicin+Cyclophosphamide) as an auxiliary therapy before ▲ surgery in patients with stage 2 triple negative breast cancer who have no treatment experience, and ▲ after surgery, administer it alone as an adjuvant therapy.

 

According to phase 3 clinical study of 1,174 people, Keytruda-antcancer chemotherapy group in preoperative adjuvant therapy significantly extended its safe survival by reducing the progression of non-permanent chemotherapy, local and remote recurrence, secondary primary cancer, and death risk from all causes by 37% compared to the risk.

 

For 36 months, the Event-free Survival was 84.5%, significantly higher than the control group of 76.8%.

 

At 15.5 months of median follow-up observation period, the pathological pCR of the adjuvant therapy before and after Keytruda surgery was 64.8%, showing a statistically significant difference compared to 51.2% of chemotherapy alone.

 

The Keytruda group showed superior pCR tendency regardless of PD-L1 expression rate.

 

Accordingly, the Ministry of Food and Drug Safety allowed Keytruda to be used as an adjuvant therapy before and after surgery without performing a PD-L1 expression test.

 

Safety was similar to the safety profile of chemotherapy and Keytruda monotherapy used in patients with Triple-Negative Breast Cancer (TNBC), and no new safety issues were reported.

 

Most immune-mediated adverse reactions appeared in preoperative adjuvant therapy, and in postoperative adjuvant therapy, they were manageable at a low grade.

 

Professor Park Yeon-hee, head of the clinical trial center at Samsung Medical Center, who participated in the clinical trial, said, "Pre-operative chemotherapy options were in high demand for new treatment options because only cytotoxic anticancer drugs were available." TNBC is considered a cancer with poor prognosis due to frequent metastasis to other organs within two to three years after diagnosis and a short survival period after recurrence, but there is no target treatment.

 

The socioeconomic burden is also high due to the relatively high proportion of young patients under the age of 50.

 

Professor Park said, "TNBC has higher benefits for early chemotherapy.

 

As a precautionary measure to reduce recurrence, Keytruda-based advanced chemotherapy is considered a cost-effective area, he said.

 

"It would be great if many patients could benefit from the rapid payment." Kim Sung-pil, executive director of MSD Korea's anticancer drug business division, also said, "We will try to proceed with Keytruda's benefit as soon as possible at TNBC.

 

As the indication of Keytruda has increased, we are recently discussing a new strategy for additional benefit at urothelial carcinoma."