Pipeline Report: August 2022 | articles

Subcutaneous administration of isatuximab through a syringe pump or on-body delivery system demonstrated similar efficacy and safety compared with intravenous isatuximab when combined with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

The FDA has granted permission for enrollment to resume in the monotherapy phase 1a portion of the phase 1/2 TakeAim Leukemia trial evaluating emavusertib in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.

REGN5458 produced durable responses with low rates of cytokine release syndrome in patients with relapsed/refractory multiple myeloma.

Cevostamab generated responses and was well tolerated in younger and older patients with relapsed/refractory multiple myeloma.

The novel third-generation EGFR inhibitor abivertinib generated a positive overall response rate and overall survival in heavily pretreated Chinese patients with EGFR T790M–mutated non–small cell lung cancer who failed treatment on a first-line EGFR TKI, according to long-term follow-up data from a phase 1/2 trial (NCT02330367).

Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer who achieved a stable response to platinum-based chemotherapy.

The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.

The FDA has granted an orphan drug designation to the fixed-dose combination capsule of the PARP inhibitor senaparib and temozolomide for the treatment of adult patients with small cell lung cancer.

The FDA has lifted a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma trial investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.

Raul Cordoba, MD, PhD, discussed the efficacy and safety findings from cohort 4 of the EPCORE NHL-2 trial, the benefits observed with epcoritamab monotherapy in patients who did not proceed to transplant, and what the addition of epcoritamab to R-DHAX/C could mean for patients with relapsed/refractory DLBCL.

The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.

The FDA has granted an orphan drug designation to THIO for the treatment of patients with small cell lung cancer.

The combination of datopotamab deruxtecan and pembrolizumab, with or without platinum-based chemotherapy, displayed promising efficacy and a manageable safety profile in patients with advanced/metastatic non–small cell lung cancer.

Amivantamab in combination with lazertinib plus carboplatin and pemetrexed elicited encouraging responses in pretreated patients with EGFR-mutant non–small cell lung cancer, according to findings from the phase 1 CHRYSALIS-2 trial.

The combination of sotorasib and the small molecule SHP2 inhibitor RMC-4630 led to an investigator-assessed objective response rate of 27% and 50% in pretreated and KRAS G12C inhibitor–naïve patients with non–small cell lung cancer, respectively.

Sitravatinib in combination with tislelizumab demonstrated a confirmed investigator-assessed overall response rate of 30.4% in patients with PD-L1–positive, treatment-naïve, locally advanced or metastatic squamous non–small cell lung cancer.

GDC-6036, a novel KRAS G12C inhibitor, produced encouraging antitumor activity with a manageable safety profile as a single agent in previously treated patients with KRAS G12C–mutated NSCLC, according to data from a phase 1a trial.

Larotrectinib continued to elicit durable responses and a low toxicity profile in patients with NTRK fusion–positive lung cancer, according to long-term follow-up data from the phase 2 NAVIGATE trial and phase 1 LOXO-TRK-14001 trial.

Ociperlimab, an anti-TIGIT monoclonal antibody, plus the anti–PD-L1 monoclonal antibody tislelizumab induced promising efficacy in adults with treatment-naïve, metastatic, PD-L1–positive non­–small cell lung cancer, according to data from the dose-expansion cohort of the AdvanTIG-105 trial.

Investigators are evaluating the combination of repotrectinib and osimertinib for the treatment of patients with advanced or metastatic EGFR-mutant non–small cell lung cancer in the phase 1 TOTEM trial.

The combination of azacitidine and quizartinib produced preliminary responses in patients with myelodysplastic syndrome and myelodysplastic syndrome/myeloproliferative neoplasms whose tumors harbored FLT3 or CBL mutations, according to data from a phase 1/2 trial (NCT04493138).

The novel PSMAxCD38 costimulatory bispecific antibody REGN5678 has shown encouraging efficacy in combination with cemiplimab in patients with advanced metastatic castration-resistant prostate cancer, according to preliminary findings from an ongoing phase 1/2 trial (NCT03972657).

The fully human BCMA-directed CAR T-cell therapy, CT103A, demonstrated deepening efficacy with an acceptable toxicity profile in patients with relapsed or refractory multiple myeloma, according to updated data from the phase 1/2 FUMANBA-1 trial.

The FDA has granted a fast track designation to OP-1250 for the treatment of patients with ER-positive, HER2- metastatic breast cancer who have progressed following at least 1 line of endocrine therapy with at least 1 line administered in combination with a CDK4/6 inhibitor.

The FDA has lifted a clinical hold on the phase 1b KEYNOTE-B79 trial, which is evaluating the safety and clinical activity of CYAD-101 given concurrently with FOLFOX and followed by pembrolizumab in patients with unresectable metastatic colorectal cancer.