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¡´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

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¤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¦¬ªº15­Ó¸Ì¥u¦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.

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