TKI - September 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
TKI - September 2020
Pivotal GEOMETRY mono-1 study results of capmatinib (Tabrecta) in patients with METex14 metastatic non-small cell lung cancer published in NEJM
02 Sep 2020
Tabrecta (Capmatinib; MET inhibitor) – Incyte/Novartis
- Data from pivotal Phase 2 GEOMETRY mono-1 study in The New England Journal of Medicine
- Results:
- ORR:
- 68% (95% CI, 48-84) among treatment-naïve patients (n=28)
- 41% (95% CI, 29-53) among previously treated patients (n=69)
- Among patients with MET amplification and a gene copy number of 10 or higher, overall response
- 29% (95% CI, 19 to 41) of previously treated patients
- 40% (95% CI, 16 to 68) of those who were treatment-naïve
- Median duration of response (mDOR)
- 6 months (95% CI, 5.6-not estimable) in treatment-naive patients (19 responders)
- 7 months (95% CI, 5.6-13.0) in previously treated patients (28 responders)
- 13/14 patients with METex14 had brain metastases at baseline (3 treatment-naïve and 10 previously treated patients) and were considered evaluable by the BIRC. In a post-hoc analysis, 7 intracranial responses were observed, including 4 complete responses
- The most common TRAE: Peripheral edema (43%), nausea (34%), increased blood creatinine (18%) and vomiting (19%). The majority of AEs were grade 1-2
- Among patients with MET amplification and a gene copy number of 10 or higher, overall response
Pivotal GEOMETRY mono-1 study results for Novartis Tabrecta published in NEJM
Share this
CI Scientists Remarks:
- In May’20, Tabrecta became the first product to get accelerated approved by the FDA to specifically target metastatic NSCLC with a METex14 mutation
- Approval was based on the results from GEOMETRY mono-1 study and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial
- In 2009, Novartis acquired the exclusive worldwide development and commercialization rights to Tabrecta from Incyte. Incyte is eligible for >$500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis
- Post launch in the US – Tabrecta received strong early market response and positive customer feedback; In Jun’20, it received approval in Japan
- To further expand the potential of the Tabrecta, Novartis is conducting:
- Monotherapy study: Phase 3, for brain metastases, tumor agnostic
- In combinations: for PD-L1 high expressers regardless of MET status, in combination with pembrolizumab; METex14 skipping regardless of PD-L1 status, in combination with spartalizumab; MET amplified post-EGFR, in combination with osimertinib
– Dr. Kowndinya, CI Scientists