Küçük hücreli akciğer kanserinde yeni tedavi seçeneği olarak Tarlatamab
Küçük hücreli akciğer kanserinde yeni tedavi seçeneği olarak Tarlatamab
Küçük hücreli akciğer kanseri %95 oranında sigara içmeyle ortaya çıkan ve agresif seyreden bir hastalık
Kemoterapi ya da kemoterapi immünoterapi kombinasyonları sonrası hastalık kısa sürede tekrarlama özeliği gösterir
Son Avrupa onkoloji kongresinde bu agresif kanser için umut veren bir molekülün etkinliği açıklandı
Evre IV küçük hücreli akciğer kanserinde daha önce tedavi almış ve seçeneği olmayan hastalar için yeni bir umut ortaya çıktı
Heyecan verici sonuçlara göre, tedavi seçeneği tüketmiş hastaların %40 yakınında hastalığın cevap verdiği görüldü.
Tarlatamab adlı molekül küçük hücreli akciğer kanserinde delta-like ligand 3 (DLL3) proteinine ve savunma hücresi T hücrelerine bulunan CD3 proteine bağlanarak savunma hücrelerini kansere karşı aktifleştiriyor.
Daha erken dönem sonuçları ve daha büyük hasta grubundaki çalışmalar merakla bekleniyor
Bu veriler ışığında, Amerika Birleşik Devletleri Gıda ve İlaç Dairesi (FDA), daha önce bir seri almış ve hastalığı ilerlemiş hastalar için Tarlatamab adlı molekül küçük hücreli akciğer kanserinde yeni tedavi seçeneği olarak onayladı.
Kaynak
ESMO2023
BACKGROUND
Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand
3 and CD3, showed promising antitumor activity in a phase 1 trial in patients with
previously treated small-cell lung cancer.
METHODS
In this phase 2 trial, we evaluated the antitumor activity and safety of tarlatamab,
administered intravenously every 2 weeks at a dose of 10 mg or 100 mg, in patients
with previously treated small-cell lung cancer. The primary end point was objective
response (complete or partial response), as assessed by blinded independent central
review according to the Response Evaluation Criteria in Solid Tumors, version 1.1.
RESULTS
Overall, 220 patients received tarlatamab; patients had previously received a me[1]dian of two lines of treatment. Among patients evaluated for antitumor activity
and survival, the median follow-up was 10.6 months in the 10-mg group and 10.3
months in the 100-mg group. An objective response occurred in 40% (97.5% con[1]fidence interval [CI], 29 to 52) of the patients in the 10-mg group and in 32%
(97.5% CI, 21 to 44) of those in the 100-mg group. Among patients with an objec[1]tive response, the duration of response was at least 6 months in 59% (40 of 68
patients). Objective responses at the time of data cutoff were ongoing in 22 of 40
patients (55%) in the 10-mg group and in 16 of 28 patients (57%) in the 100-mg
group. The median progression-free survival was 4.9 months (95% CI, 2.9 to 6.7)
in the 10-mg group and 3.9 months (95% CI, 2.6 to 4.4) in the 100-mg group; the
estimates of overall survival at 9 months were 68% and 66% of patients, respec[1]tively. The most common adverse events were cytokine-release syndrome (in 51%
of the patients in the 10-mg group and in 61% of those in the 100-mg group),
decreased appetite (in 29% and 44%, respectively), and pyrexia (in 35% and 33%).
Cytokine-release syndrome occurred primarily during treatment cycle 1, and events
in most of the patients were grade 1 or 2 in severity. Grade 3 cytokine-release syn[1]drome occurred less frequently in the 10-mg group (in 1% of the patients) than in
the 100-mg group (in 6%). A low percentage of patients (3%) discontinued tarlatamab
because of treatment-related adverse events.
CONCLUSIONS
Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activ[1]ity with durable objective responses and promising survival outcomes in patients
with previously treated small-cell lung cancer. No new safety signals were identified.
(Funded by Amgen; DeLLphi-301 ClinicalTrials.gov number, NCT05060016.)
