Ua ʻae ʻia ka noi noiʻi lāʻau hou (IND) e ka US FDA i Iune a me ka Center for Drug Evaluation (CDE) o ka National Medical Products Administration of China i ʻOkakopa i ka makahiki i hala.
He hōʻailona wehe kēia, multi-center Phase I/II clinical study me kēia mau pahuhopu: e loiloi i ka palekana o nā maʻi MIBC; e hoʻoholo i ka manaʻo ʻia ʻo Phase 2 (RP2D), a e loiloi i ka pono e like me ka neoadjuvant therapy no MIBC.
"ʻO APL-1202 i hui pū me ka tislelizumab e like me ka neoadjuvant therapy ka mea hiki ke lilo i koho lapaʻau maikaʻi loa no nā poʻe maʻi MIBC, hauʻoli nui mākou i ka hoʻokele mua ʻana o ka mea maʻi ma US," wahi a Dr. Xue Yong, MD, PhD, Chief Medical Luna ma Asieris. "Ua hiki iā mākou ke holomua i ka hoʻokolokolo ma waena o ka maʻi maʻi COVID-19 e hōʻike ana ʻaʻole wale i ka hoʻokō pono ʻana o kā mākou hui, akā ʻo kā mākou kūpaʻa hoʻi e hoʻomaikaʻi i ke olakino kanaka."
ʻO APL-1202 kahi mea hoʻopaneʻe MetAP2 hiki ke hoʻohuli ʻia me nā hana anti-angiogenic, anti-tumor a hiki ke hoʻololi i ka microenvironment immune immune. Aia i kēia manawa i ka Phase III / pivotal clinical trials ma Kina, ma ke ʻano he mea hoʻokahi ma ke ʻano he lāʻau lapaʻau mua no nā poʻe maʻi me ka maʻi maʻi maʻi maʻi maʻi ʻaʻole o ka muscle invasive (NMIBC), a i ʻole i hui pū ʻia me ka chemotherapy ma ke ʻano he lāʻau lapaʻau lua ma. nā mea maʻi me ka NMIBC kemo-refractory waena a me ke kiʻekiʻe. ʻO Tislelizumab kahi kanaka IgG4 anti-PD-1 monoclonal antibody i hoʻolālā ʻia e hōʻemi i ka hoʻopaʻa ʻana iā FcγR ma nā macrophages. Ua ʻae ka China National Medical Products Administration (NMPA) i ka tislelizumab i ʻelima mau hōʻailona, me ka ʻae piha ʻana no ka mālama ʻana i ka laina mua o nā maʻi me ka maʻi maʻi maʻi ʻaʻaʻole liʻiliʻi liʻiliʻi liʻiliʻi (NSCLC) i hui pū ʻia me ka chemotherapy a no ka mālama mua ʻana i nā maʻi. me ka NSCLC non-squamous holomua me ka chemotherapy. Ua hāʻawi pū ʻo NMPA i ka ʻae kūlana no ka mālama ʻana i nā poʻe maʻi me ka lymphoma o Hodgkin maʻamau (cHL) i loaʻa ma kahi o ʻelua mau lāʻau lapaʻau ma mua, no ka mālama ʻana i nā maʻi me ka maʻi maʻi kūloko a i ʻole ka metastatic urothelial carcinoma (UC) me ka PD-L1 kiʻekiʻe o ka maʻi i holomua i ka wā. a i ʻole ma hope o ka chemotherapy i loaʻa i ka platinum a i ʻole i loko o 12 mau mahina o ka neoadjuvant a i ʻole ka adjuvant lapaʻau me ka platinum-containing chemotherapy, a no ka mālama ʻana i nā poʻe maʻi me ka maʻi hepatocellular carcinoma (HCC) i loaʻa ma ka liʻiliʻi o hoʻokahi lāʻau ʻōnaehana. ʻO ka ʻae piha ʻana no kēia mau hōʻailona e pili ana i nā hopena mai ka hoʻomau ʻana i nā hoʻokolohua hoʻokolohua hōʻoia i hoʻopaʻa ʻia.
He aha e lawe ʻia mai kēia ʻatikala:
- NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy.
- It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC.
- The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy.
