NKTR-102, a novel investigational topoisomerase I inhibitor-polymer conjugate, is Nektar’s lead oncology candidate and is being evaluated in multiple cancer indications.
The randomised Phase 2 study evaluated two 145mg/m2 dose schedules of single-agent NKTR-102, every two weeks (q14d) and every three weeks (q21d), in 70 metastatic breast cancer patients who failed a prior taxane therapy.
87% (61/70) of patients in the study received a prior anthracycline/taxane with or without capecitabine.
A total of 66 of the 70 patients treated in the Phase 2 study were assessable for the primary endpoint of objective tumor response rate (ORR), including confirmed complete and partial responses per Recist.
In the trial, the patients treated in the single-agent NKTR-102 study had a median of two lines of prior cytotoxic treatments for metastatic disease. Seventy-three percent (51/70) of the patients received neoadjuvant and/or adjuvant therapy and 87% (61/70) had visceral disease.
Institut Jules Bordet in Brussels Medical Oncology Clinic head Ahmad Awada said that these are important new results for NKTR-102 in patients with metastatic breast cancer.
"The high confirmed objective response rate continues to show that NKTR-102 is one of the most active single agents in this disease," Awada said.
Nektar senior vice president and chief medical officer Lorianne Masuoka said that NKTR-102 is quickly emerging as a very important potential new drug in the fight against cancer.
"The drug has consistently high response rates as a single-agent in multiple Phase 1 and 2 clinical studies to-date, including our study in platinum-resistant ovarian cancer and now in metastatic breast cancer," Masuoka said.
"This clinical benefit we’ve observed in tumor settings, where a highly active topoisomerase 1 inhibitor could be extremely useful, makes us very excited about the future of NKTR-102."