MSD Korea, a unit of Merck & Co. known as MSD outside the U.S. and Canada, said Wednesday that the country approved a faster, under-the-skin version of Keytruda, the world’s top-selling cancer immunotherapy, cutting administration time from roughly 30 minutes by intravenous (IV) infusion to about one minute every three weeks or two minutes every six weeks.
The Ministry of Food and Drug Safety (MFDS) approved Keytruda SC, the subcutaneous formulation of Keytruda marketed as Keytruda Qlex in the United States, for the same adult uses as Keytruda IV, covering 35 indications across 18 cancer types, including lung cancer, triple-negative breast cancer (TNBC), gastric cancer and endometrial cancer.
MSD plans to launch the product in the fourth quarter.
The intravenous (IV) formulation of Keytruda, MSD’s PD-1 cancer immunotherapy, is approved in Korea across 35 indications in 18 cancer types. (Courtesy of MSD Korea)
The approval lands as major cancer drugmakers are trying to move blockbuster immunotherapies out of lengthy infusion schedules and into shorter injections. Roche’s Tecentriq Hybreza and Bristol Myers Squibb (BMS)’s Opdivo Qvantig have already entered the same race in the U.S.
“Patients are piling up,” Kim Sung-bae, a breast cancer oncologist at Asan Medical Center (AMC), told Korea Biomedical Review by phone on Wednesday.
Some patients arrive at large hospitals early in the morning with family members and still wait because infusion rooms are full, he said. Others are told to return the next day because no chairs are available.
In breast cancer, patients often begin with combination chemotherapy and immunotherapy before later continuing maintenance immunotherapy alone, creating repeated hospital visits that can stretch over months or years.
“At the beginning, patients still need IV chemotherapy, so vascular access is unavoidable,” Kim said. “But once patients stabilize after six or eight cycles and move into maintenance therapy, SC becomes more meaningful because patients can receive treatment quickly and go home faster.”
MSD said the approval was based on the phase 3 MK-3475A-D77 trial in previously untreated metastatic non-small cell lung cancer (NSCLC) patients without EGFR mutations or ALK or ROS1 rearrangements. The study showed pharmacokinetic (PK) noninferiority to the intravenous formulation of Keytruda and a consistent safety profile.
The company also cited a phase 2 crossover study in which 65 percent of patients who experienced both formulations preferred the subcutaneous version, mainly because they spent less time at the hospital and felt more comfortable during administration.
MSD Korea declined to discuss expected pricing. On reimbursement, the company told Korea Biomedical Review it plans to pursue coverage under the same reimbursement scope as intravenous Keytruda through a formulation-change review rather than a fresh indication-by-indication assessment.
How widely hospitals and patients switch may ultimately depend on whether shorter treatment time outweighs the inconvenience of adding another injection during combination therapy.
Professor Kim said doctors already saw rapid conversion patterns after subcutaneous versions of Herceptin and Phesgo entered breast cancer treatment.
“Initially, conversion might be around 80 percent,” he said. “But once patients experience it and word spreads that it is convenient, usually more than 90 percent switch. The treatment pattern changes.”
Still, Kim said many patients will continue needing IV chemotherapy during earlier treatment phases, while others simply prefer intravenous treatment or do not tolerate subcutaneous injections well.
“If efficacy, side effects and pharmacokinetics are comparable, then what matters becomes convenience and price,” he said.
Keytruda SC combines pembrolizumab with berahyaluronidase alfa and is administered in the thigh or abdomen, excluding the area within 5 centimeters of the navel.
Kim Ji-hye
댓글
0