Ubushinwa bwemeye ORPATHYS ivanze na TAGRISSO mu kuvura abarwayi ba kanseri y'ibihaha bafite MET Amplification nyuma yo gukomeza gukoresha uburyo bwa mbere bwo kuvura EGFR Inhibitors

Ku ya 30 Kamena 2025, HUTCHMED yatangaje ko Porogaramu nshya y'imiti (NDA) yo guhuza ORPATHYS (savolitinib) na TAGRISSO (osimertinib) yemejwe n'Ikigo cy'Igihugu cy'Ubushinwa gishinzwe Ibikoresho by'Ubuvuzi (NMPA) mu kuvura abarwayi bafite kanseri y'ibihaha idakomeye cyangwa ifata ingirabuzima fatizo (EGFR) idafite squamous non-small cell cancer (NSCLC) hamwe n'ingufu za MET nyuma y'uko indwara ikomeje kugaragara ku miti ya EGFR tyrosine kinase inhibitor (TKI). ORPATHYS ni MET TKI ikoreshwa mu kanwa, ikomeye kandi itoranywa cyane. TAGRISSO ni EGFR TKI yo mu gisekuru cya gatatu, idahinduka.

ORPATHYS ni yo miti ya mbere ya MET inhibitor yemejwe mu Bushinwa, yagenewe abarwayi bakuru bafite NSCLC yateye imbere cyangwa itera metastatic hamwe na MET exon 14 skipping alteration. Uku kwemezwa gushya kwa NMPA kwashingiye ku makuru yavuye mu igerageza rya SACHI Phase III ry’imiti ya ORPATHYS na TAGRISSO (NCT05015608), nyuma yo kugera ku ntego y’ibanze yo kubaho nta guhindagurika (PFS) mu isesengura ry’agateganyo ryari ryateguwe mbere. Ibisubizo by’ibanze byatanzwe mu nama ngarukamwaka y’Umuryango w’Abanyamerika w’Ubuvuzi bw’Imiti (ASCO) muri Kamena 2025.

Ku bijyanye n'isesengura ry'agateganyo ry'amakuru yo ku ya 30 Kanama 2024, abarwayi 211 bose hamwe bakorewe ku buryo butaziguye kugira ngo bahabwe savolitinib na osimertinib combination cyangwa chemotherapy. Mu rwego rwo kuvura (ITT), umubare w'abakora ubushakashatsi (PFS) wapimwe n'umushakashatsi wari amezi 8.2 hakoreshejwe savolitinib hamwe na osimertinib, ugereranije n'amezi 4.5 hakoreshejwe chemotherapy. Komite yigenga ishinzwe gusuzuma (IRC) yapimye ko ikigereranyo cya PFS cyari amezi 7.2 ugereranije n'amezi 4.2.

Igipimo cy’umuti wakozwe n’abashakashatsi (ORR) cyari 58% mu itsinda rya savolitinib hamwe na osimertinib ugereranije na 34% ku barwayi bo mu itsinda rya chemotherapy. Igipimo cyo kurwanya indwara (DCR) cyari 89% ugereranije na 67% naho igihe cyo kurwanya indwara (DoR) cyari amezi 8.4 ugereranije n’amezi 3.2. Muri rusange, kubaho ntibyari bigeze ku rugero rwiza mu gihe cy’isesengura ry’agateganyo.

Ibisubizo ku bushobozi bw'abarwayi bavuwe na EGFR tyrosine kinase inhibitor (TKI) bo mu gisekuru cya gatatu byagereranywa n'abo mu gisekuru cya gatatu cy'abavuwe na EGFR-TKI. Mu itsinda rito ryavuwe na EGFR-TKI ryo mu gisekuru cya gatatu, PFS yasuzumwe n'iyasuzumwe na IRC yari isanzweho, haba mu mezi 6.9 ugereranyije na 3.0.

Umutekano w’umuti wa savolitinib na osimertinib wari wihanganirwa kandi nta bimenyetso bishya by’umutekano byagaragaye. Ingaruka mbi z’ubuvuzi bw’abantu bo mu cyiciro cya 3 cyangwa kirenga zagaragaye kuri 57% by’abarwayi bo mu itsinda rya savolitinib hamwe na osimertinib ugereranije na 57% ku barwayi bo mu itsinda rya chimiotherapie, bigaragaza ko umutekano wabo wari mwiza.

Ku bijyanye na ORPATHYS

ORPATHYS (savolitinib) ni MET TKI yo mu kanwa, ikomeye kandi itoranya cyane yagaragaje imikorere mu buvuzi mu tubyimba tw’umubiri. Ibuza uburyo budasanzwe bwo gukora inzira ya MET receptor tyrosine kinase ibaho bitewe n’impinduka (nk’impinduka za exon 14 skipping cyangwa izindi mpinduka), kongera imiterere y’uturemangingo cyangwa poroteyine nyinshi.®

Ku bijyanye na TAGRISSO®

TAGRISSO (osimertinib) ni EGFR-TKI yo mu gisekuru cya gatatu, idakira kandi ifite imikorere yagaragaye muri NSCLC, harimo no kurwanya indwara za CNS. TAGRISSO (ibinini 40mg na 80mg binyobwa rimwe ku munsi) yakoreshejwe mu kuvura abarwayi bagera ku 800.000 mu bimenyetso byayo ku isi yose, kandi AstraZeneca ikomeje gushakisha TAGRISSO nk'uburyo bwo kuvura abarwayi mu byiciro bitandukanye bya EGFRm NSCLC.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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