The U.S. Food and Drug Administration (FDA) recently approved Penpulimab-kcqx. This groundbreaking monoclonal antibody that targets programmed death 1 has recently gained approval for use in NPC. Penpulimab-kcqx was approved for use in combination with platinum-based chemotherapy. This positions it as a first-line treatment option for patients with recurrent or metastatic non-keratinizing NPC. Furthermore, it will be a potent and selective single-agent therapy. It is intended for patients with metastatic disease that has progressed following platinum-based chemotherapy and at least one other line of therapy.
This transformative therapy will help broaden scarce treatment options for NPC patients with few other alternatives. The approval of Penpulimab-kcqx is based on the results of one or more pivotal studies showing that it works. The AK105-202 Study enrolled only 125 patients with unresectable or metastatic non-keratinizing NPC. The AK105-304 trial enrolled 291 previously untreated patients with metastatic disease.
The Prescribing Information has a recommended dosing regimen of 200 mg every three weeks. This regimen is continued in combination with either cisplatin or carboplatin and gemcitabine until disease progression or development of unacceptable toxicity, for a maximum of 24 months. For patients receiving Penpulimab-kcqx monotherapy, the recommended dosage of Penpulimab-kcqx is 200 mg. This should be required every two weeks under the same conditions.
The results from these studies show very positive outcomes at 12 months of follow-up. In their treatment group, 31% of patients were alive and progression-free at the conclusion of the study—compared to just 11% in the placebo group. The median progression-free survival for patients on Penpulimab-kcqx was 9.6 mo. In comparison, it was just 7.0 months for the placebo group, resulting in a hazard ratio of 0.45.
Even with such favorable efficacy results, the treatment is not without risks. Fatal adverse reactions were reported in 1% of patients treated with Penpulimab-kcqx, including fatalities due to pneumonitis, septic shock, colitis, and hepatitis. We witnessed our first immune-mediated adverse reaction. These ranged from pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal impairment to different skin reactions.
Patients treated with Penpulimab-kcqx monotherapy experienced common adverse reactions in at least 20% of patients. These were hypothyroidism and musculoskeletal pain. When used in combination with cisplatin or carboplatin and gemcitabine, adverse reactions included nausea, vomiting, fatigue, rash, and COVID-19 infection among others.
The development and approval of Penpulimab-kcqx embodies a remarkable achievement to better serve NPC patients.
“Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation for the NPC indications, highlighting the crucial unmet need for this therapy.” – Akeso press release
“According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presenting with locally advanced disease.” – Akeso
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