Table 3.

Activity of RXDX-105

Alteration-based enrichment
RET fusion–positiveRET-alteredBRAFV600E-mutantHistology-based enrichment
CohortNSCLC TKI-naïve (n = 31)NSCLC prior TKI (n = 9)Other solid tumor TKI-naïve (n = 1)NSCLC TKI-naïve (n = 7)CRC TKI-naïve (n = 9)Other non-melanoma solid tumor(n = 8)Squamous cell lung cancer (n = 9)Other cancers(n = 23)
Complete response1 (4%)
Partial response6 (19%)
Stable disease12 (39%)3 (33%)1 (100%)3 (43%)4 (45%)3 (38%)3 (33%)9 (39%)
Progressive disease10 (32%)4 (45%)1 (14%)2 (22%)1 (12%)3 (33%)7 (30%)
Unevaluable3 (10%)2 (22%)3 (43%)3 (33%)4 (50%)3 (33%)6 (26%)
ORR (95% CI)19% (8–38%)0% (0–34%)0% (0–98%)0% (0–41%)0% (0–34%)0% (0–37%)0% (0–34%)4% (0–22%)
  • NOTE: In the phase Ib portion of this study, eight cohorts of patients were treated with RXDX-105. In the molecularly enriched cohorts, RET fusion–positive NSCLCs, RET-altered other solid tumors, and BRAFV600E-mutant NSCLCs, colorectal cancers (CRC), and other non-melanoma solid tumors were accrued. The best objective response to therapy is listed for each cohort along with the ORR. With the exception of one complete response in a patient with a colorectal cancer harboring a CCDC6–RET fusion, response to RXDX-105 was observed only in TKI-naïve patients with RET fusion–positive lung cancers.