חדשות
×-FDA ××שר ××ק×××× ×××פ×× ××××× NSCLC ×שר ××פ×× ×קר×××××× ××
18/05/2014
×××××¢× ××¢×ת×× ×ת ש×צ×× ×ש×××¢, ×××××¢× ××רת × ××ר××ס ×× ×× ×× ××××× ××תר×פ×ת ×××ר×ק×× (×-FDA) ××שר ×ת ××ק×××× (סר×××× ××, × ×§×¨×× ××¢×ר LDK378) ×××פ×× ××××פ××× ×ס××××× ×סר×× ×¨×××ת ×ר××¨×ª× (NSCLC) ×××××× ×-anaplastic lymphoma kinase) ALK+).
×תר××¤× ×××©×¨× ×××פ×× ××××פ××× ×©××××ª× ×תק××× ××××× ×××פ×× ×קר×××××× ×× ×× ×©××× ×¨××ש×× ×תר××¤× â[1].
××ש××¨× ×©× ××ק×××× ×¢×× × ×¢× ×¦××¨× ×¨×¤××× ×©× ×××פ××× ×ס××××× ×סר×× ×¨×××ת ×ס×× ×× ×××××× ×©××× ×תק××× ××××× ××פ×× ×§×××.
×××ת ×-ALK+ NSCLC × ××עת ××ר××× ×××ש ×©× ×× ×-ALK ×××ר×× ×צ×××ת ת×× ×סר×× ×-2â7% ×××××פ××× ×ס××××× ×-NSCLC2
סר×× ×ר×××ת ×× ×¤××¥ ×××תר ××× ×-NSCLC, ××××× 85%â90% ×××× ××קר×× â[2]. ×ת×× ×××, 2%â7% × ×××¢×× ××ר××× ×××ש ×©× ××× ALK ×××××ר ×ת ×××××ª× ×©× ×ª×× ×סר××, ×× ××ª× ×××××× ××××× ×××ק×××¨× ×¢× ×¨×§×ת ×××××× â[3].
××ר×ת ××תק×××ת ×× ××רת ×©× ×ª××× ×××פ×× ××××פ××× ×ס××××× ×-ALK+ NSCLC, ×עת×× ×§×¨×××ת ×××רת ××××× ××× ×××ª× × ×× ×¢×ª, ××ש צ××¨× ××פשר×××ת ××פ×× × ×ספ×ת.
××ש××¨× ×©× ××ק×××× ×××סס ×¢× × ×ס×× ×ר××× ×©××× 163 ×××פ××× ×©×¡××× ×סר×× ALK+ NSCLC ×ר××¨×ª× ×××××ª× ×תק××× ××××× ×××פ×× ×קר×××××× ×× ×× ×©×× ××× ×¨××ש×× ×תר×פ×. ××ר×ר×ת ×× ×¤×צ×ת ×××תר ××××××ס××ת ××××פ××× ×©× ××§×¨× ××× ××ק×××ת ×××××: ××× (60%), ××× (42%) ×עצ××ת (42%)â[1].
ש××¢×ר ×ת×××× ××××× (ORR) ×©× ××ק×××× ××§×¨× ×××פ××× ×©××פ×× ××¢×ר ××× 54.6% [CI 95%, 47%â62%], ×××©× ×ת×××× ××צ××× × (DOR) ××× 7.4 ×××ש×× [ר××× ×ר ס×× 95%, 5.4â10.1 ×××ש××] â[1]. ×××ר××¢×× ××ר×××× ×× ×¤×צ×× ×××תר (×ש××××ת 25% ×פ××ת) ××× ×©×ש××, ×××××, ×¢×××× ×ר×ת ×× ×××× ××ר×× ×¡×××× ×××ת, ×ק××ת, ××× ×××, ×¢××פ×ת, ×ר××× ×ת××××× ×עצ×ר×ת â[1].
××ק×××× ××× × ×ª×¨××¤× ×¤×××ת ×××¢××ת ××××¤× ×¡×ק×××× ×ת ALK, ש××× ×× ×××¨× ×ש×× ×××פ×× ×סר×× ×¨×××ת. ×-ALK ××× ×× ××ס××× ××ת×××ת ×¢× ×× ×× ××ר×× ×××צ×ר "××××× ×××ר×" ×××¢××× ×ת ×תפת×××ª× ×צ××××ª× ×©× ×ª×× ×¡×¨×× â[4] , â[5].
××ק×××× ××× ××ת ××תר×פ×ת ×ר×ש×× ×ת ש×××©×¨× ×××ר ס×××× ×-breakthrough therapy ×¢× ××× ×-FDA â ס×××× ×©×תק×× ××רס 2013 ×¢×§× ×××××ק×ת ×©× ×ת×צ××ת ש×תק××× ×× ×ס×× ××ר××× ××¢×§× ××פ××× ××××ר ××ס×× ××××× ×©× ×××ת ×-ALK+ NSCLC. ××ק×××× ××ת×× × ×××ש×ר ××ש×ת × ×ספ×ת ××ק×××ת ש×× ×× ××¢×××, ×ר××ת ×××©× ×××××× ×××ר×פ×.
×× ×ס×× ××ר××× ×ת××× ×ת ×× ×ס×××× ×ק××× ××× ×¢× ××ק××××
××¢××××ª× ×©× ××ק×××× ××××× ×× ×ס×× ×¨×¤××× ×¨× ×ר×××, ×× ×ר××¢× ×פת××.
×× ×ס×× ××©×ª×ª×¤× 163 ×××פ××× ×©×¡××× ×-ALK+ NSCLC ×ר×רת×ת ××שר ××××× ×©××× ×תק××× ××××× ×××פ×× ×קר×××××× ××, ×× ×©××× ×¨××ש×× ×××פ××. ××שתתפ×× ××פ×× ×××ק×××× ×××× ×× 750 ×"× ×¤×¢× ××××.
××× ××ער×× ××¢××§×¨× ×××¢×××ת ××× ORR ××ת×× ×קר××ר××× ×× ×©× RECIST v1.0, ××¤× ×ער××ª× ×©× ×××קר×× ××©× ××¢×ת ××××§× ×××ª× ×ª×××× ×©×¤×¢×× ×ª×ת ס×××ת (BIRC). ×-DOR ××× ××× ×ער×× × ×סף â[1].
××פ××× × ×××××ס××ת ×××קר ×××: ××× ×צ××× × 52, ××× ×ת×ת ×-65 (87%), × ×©×× (54%), ××× ×× (66%), ×ס××ת××× (29%), ×× ×¢××©× × ××¢××× ×× ××¢×©× ×× ×שע×ר (97%) ר×ת ×תפק×× ××¤× ECOG 1 ×× 2 (87%), ×תק×××ת ××××× ××××× ××פ×× ×§××× ×קר×××××× ×× (91%), ×ספר ×××פ×××× ×ק××××× 2 ×× ××תר (84%) ×××פ××× ×× ×©× ××× ×קרצ×× ××× ×××ס××××××× (93%).
××ק×××ת ש××× × ×צ×× ×ר×ר×ת ××××¥ ×××ת ×××× ×××× ××× (60%), ××× (42%) ×עצ××ת (42%). ×××××××ת ×-ALK ××××ª× ××××¤× ×¨×ר×ספק×××× ×¢× ××× ×¡×§××¨× ×©× ×ת×צ××ת ××ק××××ת ×-99% ×××××פ××× â[1].
ש××¢×ר ×-ORR ×©× ××ק×××× ××× 54.6% [CI 95%, %47â62%], ××-DOR ××צ××× × ××× 7.4 ×××ש×× [CI 95%, 5.4â10.1 ×××ש××] ××¤× ×ער×ת ×××קר.
×× ×ת×× ××¤× ×ער×ת ×-BIRC ××× ×××× ×× ×ת×× ××¤× ×ער×ת ×××קר: ש××¢×ר ×-ORR ש×תק×× ×× ××× 43.6% [CI 95%, 36%â52%], ××-DOR ××צ××× × ××× 7.1 ×××ש×× [CI 95%, 65.âNE ×××ש××] â[1].
× ×ס×× ×× ××× ××ק ×ת××× ×ת ×× ×ס×××× ×ק××× ××× ××ת×ש×ת ×©× × ××ר××ס ××××××ס××ת ××××פ××× ×××ת. ×××× × ×¢×¨××× ××× ××קר×× ×××××× ××××קת ×××פ×× ×סר×××× ××, ×××תר ×-300 ×ר××× ××קר ×××תר ×-30 ×××× ×ת.
×©× × × ×ס×××× ×§××× ××× ×©×× II ×× ×ר××¢××× ×¢× ×××פ××× ×ס××××× ×-ALK+ NSCLC ××שר ××פ×× ××¢×ר ×× ×©×× ××פ×× ××¢×ר (× ×§×¨××× ×-www,clinicaltrials.gov NCT01685060 ×-NCT01685138) × ×צ××× ×××× ××¢×צ××× ×××ר ש××××¡× ××××× ×ספר ××××פ××× ××ת××× ×.
×× ×סף ×××, ×©× × × ×ס×××× ×§××× ××× ×©×× III ××ש×××× ×ת סר×××× ×× ×××××תרפ×× ××××פ××× ×©××פ×× ××¢×ר ×× ×©×× ××פ×× ××¢×ר (× ×§×¨××× ×-www,clinicaltrials.gov NCT01828099 ×-NCT01828112) × ×צ××× ×××× ××¢×צ××× ×××××ס×× ×××פ××× ××××¤× ×¤×¢×× ×ר××× ××¢××× â[6], â[7], â[8], â[9].
××ק×××× ××××צת ×××פ×× ××××פ××× ×ס××××× ×-ALK+ NSCLC ×ר×רת×ת ש××××ª× ×תק××× ××××× ×××פ×× ×קר×××××× ×× ×× ×©××× ×¨××ש×× ×תר×פ×.
×ת××××× ×× ×§×××× ××ש×ר ××××¨× ×¢× ×¡×× ×©××¢×ר ×ת×××× ×©× ×××××××× ×××©× ×ת××××. ××¨× ×××× ×©×פ×ר ×××שר××ת ×× ×תס××× ×× ×קש×ר×× ×××××. ×××©× ×××ש×ר ×©× ×ת××××× ×× ×¢×©×× ××××ת ת××× ×××××ת ×ת×צ××ת ××ת×××ר ת××¢×ת ק××× ×ת ×× ×ס×××× ××שש××.
×××××××רפ××
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השינוי האחרון נעשה בֹ־25 במאי 2014 ב־18:41