The Targeted Pulse: IBI363’s Fast Track Status Set to Transform Melanoma, Subcutaneous Bortezomib Receives Approval for MM and MCL Management, and More

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IBI363 Set to Transform Melanoma Treatment With FDA Fast Track Status

IBI363 has received FDA fast track designation for treating unresectable locally advanced or metastatic melanoma that has progressed after at least 1 line of systemic therapy, including a PD-(L)1 inhibitor. This agent is a PD-1/IL-2α bispecific antibody fusion protein. Data from a phase 1/2 trial (NCT04085185) support this designation, which evaluated 37 patients with pretreated melanoma who received 1 mg/kg of IBI363.

“…IBI363 has demonstrated strong antitumor effects, which could potentially be the next breakthrough in this area. Moreover, a promising efficacy signal was shown in [immuno-oncology (IO)]-naive mucosal melanoma, a relatively ‘cold’ tumor, which brings us great confidence in the next step to expand the IO-naive population and also indicates the broad application potential of IBI363,” Hui Zhou, MD, said during a presentation of the data.

Subcutaneous Bortezomib Approved for Multiple Myeloma and Mantle Cell Lymphoma

The FDA has approved a ready-to-use, subcutaneous formulation of bortezomib (Boruzu) for treating multiple myeloma and mantle cell lymphoma. This new version simplifies administration by reducing the need for compounding preparation. It is expected to launch in the second quarter of 2025. Data from a phase 3 noninferiority study (NCT00722566) demonstrated that the formulation is both safe and effective.

“The approval of Boruzu is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians,” said Sean McGowan, vice president of biosimilars and branded oncology at Amneal Pharamaceuticals, in a press release.

Innovative Lenvatinib/Pembrolizumab Duo Shakes Up Non-Clear Cell RCC Treatment

Recent treatment developments for non-clear renal cell carcinoma (nccRCC), highlight the efficacy of combining lenvatinib (Lenvima) with pembrolizumab (Keytruda). Laurence Albiges, MD, PhD, presented new data at the 2024 Kidney Cancer Research Summit in Boston, Massachusetts, providing insights into various nccRCC subtypes, including papillary, chromophobe, translocation, fumarate hydratase (FH) deficient, renal medullary, collecting duct, and unclassified.

“The good news is that we have more and more specific information on the [approaches available] for different entities. The caveat is that these are small numbers of patients, and it’s not easy to draw any definitive conclusion,” Albiges, department head of oncology at Gustave Roussy in Villejuif, France, said in a presentation of the data.

Is Imatinib Still the Best Option for CML? A Cost and OS Analysis For Front-Line TKIs

To advance tyrosine kinase inhibitors (TKIs) to the front line for chronic myeloid leukemia-chronic phase, overall survival (OS) and cost-effectiveness must be carefully evaluated, according to a presentation at the 12th Annual Meeting of the Society of Hematologic Oncology 2024. In the presentation Elias Jabbour, MD, compared the OS and cost-effectiveness of various TKIs against generic imatinib.

“Before generic imatinib was available, treatment-free remission for second-generation TKIs was cost-effective, but that has changed,” Jabbour said. “For any TKI to have a good treatment value, it has to cost less than $40,000 per year to be cost-effective,” he added.Jabbour, is professor in the Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston.

Immunotherapy Opening New Frontiers in the Treatment of T-Cell Malignancies

Stefan K. Barta, MD, MS, presented an in-depth overview of immunotherapies in T-cell lymphomas, targeting both surface antigens and immune checkpoints, at the 12th Annual Meeting of the Society of Hematologic Oncology 2024. Despite challenges with chimeric antigen receptor T-cell therapy, such as fratricide and antigen-sharing issues, innovative strategies such as antigen reduction and gene editing are showing promise in improving outcomes for these malignancies. Barta also highlighted encouraging results from the COBALT-LYM (NCT04502446) and LibrA T1 (NCT03590574) trials, which explored these groundbreaking developments.

“Most of our experience with T-cell lymphoma has been with therapies that target PD-1 and PD-L1 inhibitors, and several clinical trials have been performed evaluating single agents,” Barta, leader, T-Cell Lymphoma Program, Abramson Cancer Center, University of Pennsylvania in Philadelphia, said. “We have seen modest responses that may depend on the [T-cell lymphoma] subtypes,” Barta added.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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