Cancer

Multiple novel combos of PD-(L)1 x VEGF-targeting bispecific antibodies and antibody-drug conjugates progressed through the clinic this year, many of which are from Chinese developers and with some advancing to first-line regimens.

Positive topline data from the EV-304/KEYNOTE-B15 Phase III trial in cisplatin-eligible muscle invasive bladder cancer follows hot on the heels of the combination's stellar results in chemotherapy-ineligible patients.

The companies presented 52-week data from the pivotal Phase III VERIFY study at the recent American Society of Hematology meeting, after releasing 32-week data earlier this year.

The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.

Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.

J&J's late-breaking Phase III MajesTEC-3 data at the American Society of Hematology meeting highlighted curative potential for the bispecific T-cell engager in multiple myeloma.

To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.

Data from the Phase III BRUIN CLL-313 trial presented at ASH showed clear superiority for the non-covalent BTK inhibitor as a single agent compared with bendamustine/rituximab.

The company presented Phase II results at ASH that lend support to an ongoing Phase III trial of the CELMoD drug in maintenance therapy of multiple myeloma.

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.

The US FDA’s accelerated approval makes sevabertinib the second drug for that patient segment after BI’s Hernexeos, which won accelerated approval in August.