Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Neladalkib (NVL-655), NVL-655
Neladalkib · 2 trials · 4 indications
Time from randomization to BICR-assessed radiographic disease progression or death
Define the dose limiting toxicities (DLTs)
To determine the RP2D
To determine ORR as assessed by BICR
Incidence and severity of treatment-emergent adverse events (TEAEs)
To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of repaglinide
To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of midazolam
To determine the effect of itraconazole on the single oral dose PK of neladalkib (NVL-655)
| Arm | Type | Description |
|---|---|---|
| Neladalkib (NVL-655) | EXPERIMENTAL | 150mg taken orally once daily (QD) |
| Alectinib | ACTIVE_COMPARATOR | 600mg taken orally twice daily (BID) |
| Phase 1 dose escalation | EXPERIMENTAL | Neladalkib (NVL-655) oral daily dosing |
| Cohort 2a | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. |
| Cohort 2b | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. |
| Cohort 2c | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed. |
| Cohort 2d | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed. |
| Cohort 2e | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts. |
| Cohort 2f | EXPERIMENTAL | Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists. |
| Cohort G (DDI sub-study) | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI |
| Cohort H (DDI sub-study) | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI |
| Name | Type | Description |
|---|---|---|
| Neladalkib (NVL-655) | DRUG | Oral tablet of Neladalkib (NVL-655) |
| Alectinib | DRUG | Oral capsule of alectinib |
| Midazolam | DRUG | Oral Solution of Midazolam |
| Repaglinide | DRUG | Oral Tablet of Repaglinide |
| Itraconazole | DRUG | Oral Solution of Itraconazole |
Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 3. No prior systemic anticancer t...
Neladalkib is an investigational oral medicine being studied for locally advanced or metastatic solid tumors and non-small cell lung cancer that harbor an ALK rearrangement or activating ALK mutation. It is also being evaluated in patients with advanced ALK-positive NSCLC who have not previously received a tyrosine kinase inhibitor.
Neladalkib targets ALK, a kinase whose rearrangements and activating mutations drive certain solid tumors and non-small cell lung cancers. By inhibiting ALK kinase activity, the small molecule is designed to act on cancers that depend on ALK signaling. It is being developed by Nuvalent, Inc. (ticker NUVL).
Neladalkib is being developed by Nuvalent, Inc., which trades under the ticker NUVL. Nuvalent holds the program and is running the clinical studies evaluating the drug in ALK-positive non-small cell lung cancer and other ALK-altered solid tumors.
Neladalkib is in clinical development and is not approved. It is being studied in a Phase 1 trial and a Phase 3 trial. The Phase 3 study, NCT06765109, is recruiting and is evaluating neladalkib in TKI-naive patients with advanced ALK-positive non-small cell lung cancer.
Neladalkib is being evaluated in two recruiting studies. NCT05384626, known as ALKOVE-1, is a Phase 1 trial in advanced NSCLC and other solid tumors with ALK rearrangement or activating ALK mutation, with enrollment of 840. NCT06765109 is a Phase 3 trial in TKI-naive patients with advanced ALK-positive NSCLC, with enrollment of 450.
Yes, neladalkib and NVL-655 refer to the same investigational drug. NVL-655 is the code name used by the developer, Nuvalent, Inc., and neladalkib is the drug's name. Both names appear in the trial titles for the ALKOVE-1 Phase 1 study and the Phase 3 study in TKI-naive ALK-positive NSCLC.