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¤ý¤X¬Â¤j¡A½Æ²ß¤@¤U¥H«eªº¤À¨É¡A¦A¥[¤J³Ì·s¸ê°T¡I ¡´Nektar+keytruda & Nektar+Tecentriq¡÷ Merck & Roche¨Ã¨S¦³©MNektar¦X§@¡A´N¬ONektar¦Û¤v ¶RÃÄ°µªº¬ã¨s¡I¡I¡I¥h¦~©³¶i¦æ¨ìPhase 1!!! Nektar+Opdivo¡÷¬Ý°_¨Ó«D±`¦³·dÀYªº²Õ¦X¡÷2016/09¤ë¶}©lªº¦X§@¬ã¨s¡A¥Ø«e¨ìPhase1/2 Nektar & BMS¦@¦Pt¾á¬ã¨s¶O¥Î¡A¦ý¬O©Ò¦³ªºÅv§Q³£ÂkNektar 100%¾Ö¦³¡I ¤U±ªº¼Æ¾Ú¬O²Ä32©¡SITC¸Ì³ø§iªº¼Æ¾Ú¡I First Data for NKTR-214 in Combination with OPDIVOR (nivolumab) for Patients with Stage IV Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers, Including Patients with PD-L1 Negative Status, Revealed at SITC 2017 NKTR-214 is an investigational immuno-stimulatory therapy designed to expand and activate specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of cell-surface PD-1 on these immune cells. NKTR-214 preferentially binds to the CD122 receptor on the surface of cancer-fighting immune cells in order to stimulate their proliferation. ¡´NKTR-214¥Dn´N¬O§@¥Î¦bT²ÓM,NK²ÓM³o¨Çimmune cellªºCD122±µ¨ü¾¹¤W,¨ë¿E³o¨Çimmune cellªº¼W¥Í¡A ¦P®É¤]¥i¥H¤W¤É³o¨Çimmune cellªºPD1ªí¹F²v¡C ¡´©Ò¥H³o¨Ã¤£¯à»¡¬OADIªº«l¼Ä,¦]¬°¾÷Âण¦P,¥u¯à»¡¬OÄv¦XªºÃö«Y,¥i¥H¬OÄvª§(ÁpÃĬۤñ®É)¤]¥i¥H¦X§@(¦@¥Î®É) ¨Ó¬Ý¤@¤Udata¤ñ¸û¹ê¦b 2017¦~©³ªº¸ê®Æ ¡´¡´¡´Nektar+Opdivo ¤@½uªvÀømelanoma stage IV Advanced Treatment-Naive 1L Melanoma Patients (Stage IV): ORR= 7/11 (63%) CR=2 PR=5 ¥§¡µo¥Í®ÄªGªº®É¶¡= 1.7 months DCR(CR + PR + 3 SD)= 91%. All 7 patients with responses continue on treatment in the trial. ¡´2018/06/02¤½§Gªº¼Æ¾Ú •Stage IV Metastatic Treatment-Naïve 1L Melanoma Patients (Enrolled Per Fleming 2-Stage Design at RP2D):◦ ORR in Stage 1 (N1=13)=11/13 (85%) either (PR) or (CR). Median time on study for 28 patients in Stage 2 (N1+N2) is 4.6 months. ORR in Stage 2 (N1+N2)= 14/28 (50%) patients (3 CR, 10 PR, 1 uPR). ¡´³o¸Ì«Ü¦³½ì¡A±q²Ä¤@¦¸¦¬¤F13Ó¯f¤H«á¡A¤S¦A¦¬ªº15Ӹ̥u¦³3Ó¦³¤ÏÀ³(11/13---->14/28) ¡´©Ò¥H¬°¤°»ò»¡n=30¤~¦³°Ñ¦Ò»ùÈ------------«ÂI´N¦b³o¸Ì¡I Amongst the 25 patients with known PD-L1 status, ORR in PD-L1 negative patients= 5/12 (42%)----------¡´³oÓ¤ñ¸û¦³·N«ä¡A¬Ý°_¨Ónektar¬O¥i¥H¤W¤ÉPD-L1 expressionªº¡I ORR in PD-L1 positive patients= 8/13 (62%). One patient with unknown PD-L1 baseline status experienced a CR. °¨¤W©MIDO+Keytrudaªº¤@½uªvÀømelanoma stage IV¤ñ¤@¤ñ ORR= 35/63 (56%)---------------¡´´N³o¤@ÂI¨Ó¬Ý¬OÀu©óNektar+OpdivoªºORR in Stage 2 (N1+N2)= 14/28 (50%)ªº¡I CR= 9/63 (14%) PR= 26/63 (41%) DCR(CR + PR + 10 SD)= 71% mPFS= 12.4 months PFS 6months=65%; 12 months=52%; 18months=49% ¡´Nektar+Opdivo¥u¦³28Ó¯f¤H¡AIDO+Keytruda¦³63Ó¯f¤H¡A¯f¤H¦¨ªø2.5¿®É¡ANektar+OpdivoÁÙ¦³¤ì¦³¦P¼ËªºORR 50%³£«ÜÃø»¡¡H ¡´IDO+Keytruda¦³PFS¡I¡I¡INektar+OpdivoÁÙ¨S¦³¡I¡I¡I §Y«KIDO+Keytruda¤@¶}©l¬Ý°_¨Ó¤£¿ù¡A«á¨ÓÁÙ¬O¥¢±Ñ¤F¡IA Phase 3 clinical trial evaluating a combination of Keytruda and epacadostat in metastatic melanoma ECHO-301/KEYNOTE-252 n= 700 patients, randomized 1:1, stratified by tumor PD-L1 expression (positive versus negative/indeterminate) BRAF mutation status (¤À´¿±µ¨ü¹LBRAFªvÀø¡B¨S¦³±µ¨ü¹LBRAFªvÀøand BRAF wild-type) Keytruda¥¼¯à©úÅã§ïµ½µL¶i®i¥Í¦s´Á¡]PFS¡^¡C ¥¿½TÂI»¡À³¸Ó¬O----Keytruda+IDO(¹êÅç²Õ) vs. Keytruda³æ¿W¥ÎÃÄ(¹ï·Ó²Õ)¡AKeytruda+IDO(¹êÅç²Õ) ¥¼¯à©úÅã§ïµ½µL¶i®i¥Í¦s´Á¡]PFS¡^¡A¥BOS------- also is not expected to reach statistical significance. ©Ò¥H¡÷³o¬O²Îp¤Wªº¥¢±Ñ¡A´N¬O»¡¦h¥[¤F¤@ÓIDO¨Ã¨S¦³¤°»ò·N¸q¡I ¥u¬O¤]¨S¤°»òÃa³B¡A¦]¬° The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA. ¡´¦]¬°ADI¨Ã¨S¦³ÁpÃĪºmelanoma¡A©Ò¥HµL±q¤ñ°_¡I ¡´Nektar+Opdivo·|¦¨¥\¶Ü¡HÀR«Ý§a~~ 2017¦~©³ªº¸ê®Æ ¡´¡´¡´Nektar+Opdivo ¤@½uªvÀøRenal Cell Carcinoma Stage IV ¡´°w¹ï¥u±½´y¤j©óµ¥©ó¤@¦¸ªº¯f¤H ORR= 6/13 (46%) CR=1 PR=5 ¥§¡µo¥Í®ÄªGªº®É¶¡= 1.9 months DCR(CR + PR + 5 SD)= 85% ¡´°w¹ï¥u±½´y¤j©óµ¥©ó¡´¨â¦¸¡´ªº¯f¤H ORR= 6/10 (60%) CR=1 PR=5 |
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