Oncology Drug Approval Decisions Expected in May 2024

The US Food and Drug Administration (FDA) is expected to decide whether to approve rivoceranib in combination with camrelizumab for unresectable hepatocellular carcinoma (HCC) next month.

The FDA is also expected to decide whether to approve lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a BTK inhibitor.

Rivoceranib Plus Camrelizumab for HCC

Prescription Drug User Fee Act (PDUFA) date: May 16, 2024

Elevar Therapeutics is seeking approval for rivoceranib in combination with camrelizumab as first-line treatment for unresectable HCC. Rivoceranib is a VEGFR2 inhibitor, and camrelizumab is a PD-1 inhibitor.

The new drug application for this combination is supported by data from the phase 3 CARES 310 study (ClinicalTrials.gov Identifier: NCT03764293).¹ This study included 543 adults with advanced HCC who had not previously received systemic therapy.

The patients were randomly assigned to receive rivoceranib plus camrelizumab or sorafenib. Rivoceranib plus camrelizumab significantly improved progression-free survival (PFS) and overall survival (OS).

The median PFS was 5.6 months with camrelizumab and rivoceranib and 3.7 months with sorafenib (hazard ratio [HR], 0.52; 95% CI, 0.41-0.65; P <.0001). The median OS was 22.1 months and 15.2 months, respectively (HR, 0.62; 95% CI, 0.49-0.80; P <.0001).

Liso-Cel for FL

PDUFA date: May 23, 2024

Liso-cel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy that is already approved under the brand name Breyanzi to treat:

• Adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
• Adults with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B FL who have:
  • disease refractory to first-line chemoimmunotherapy or relapse within 12 months
    of first-line chemoimmunotherapy
  • disease refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age
  • relapsed or refractory disease after 2 or more lines of systemic therapy.

Bristol Myers Squibb is seeking approval for liso-cel to treat adults with relapsed or refractory FL. The supplemental biologics license application (sBLA) for this indication is supported by data from the TRANSCEND FL trial (ClinicalTrials.gov Identifier: NCT04245839).²

This phase 2 trial was designed to evaluate liso-cel in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including high-risk FL. There were 101 FL patients who had received at least 2 prior lines of therapy and were evaluable for efficacy after liso-cel.

The objective response rate (ORR) was 97.0%, and the complete response (CR) rate was 94.1%. The median duration of response and median PFS were not reached at a median follow-up of 16.6 months and 17.5 months, respectively.

Liso-Cel for MCL

PDUFA date: May 31, 2024

Bristol Myers Squibb is also seeking approval for liso-cel to treat relapsed or refractory MCL. The sBLA for this indication is supported by data from the TRANSCEND NHL-001 trial (ClinicalTrials.gov Identifier: NCT02631044).

The MCL cohort of this phase 1 trial included 88 patients with relapsed or refractory MCL who had received 2 or more prior lines of therapy and were infused with liso-cel.³ At a median follow-up of 16.1 months, the ORR was 83.1%, and the CR rate was 72.3%. The median duration of response was 15.7 months, and the median PFS was 15.3 months.

This article originally appeared on MPR