Elranatamab

Pfizer’s positive Phase 3 data in multiple myeloma: The company’s Elrexfio produced a “statistically significant and clinically meaningful improvement” in progression-free survival in patients with relapsed or refractory disease who had received at least one prior treatment. Pfizer plans to share detailed results at a future medical meeting and with regulators. Elrexfio secured a US accelerated approval in 2023 for patients who have received at least four prior lines of therapy. — Ayisha Sharma ICON’s audit flags “overstated” revenues: The CRO said its internal probe into accounting practices and controls found it had overstated revenues in 2023 and 2024 by less than 2%. The company plans to correct results for those two years, as well as for the first nine months of 2025. When ICON first announced the audit in February, its shares $ICLR took a hit . They were up about 9% on Wednesday’s news. — Ayisha Sharma Biohub commits $500M to launch virtual biology initiative: The initiative is meant to serve as an open data source for “AI-accelerated biology” that’s free for the scientific community. Biohub will spend $100 million to help coordinate global data generation efforts, and another $400 million to generate said data and develop next-generation technologies. — Ayisha Sharma Scottish biotech secures $25M for IBS program: Glasgow-based EnteroBiotix will use the funds to advance its full-spectrum microbiome therapeutic, called EBX-102-02, into a Phase 2b trial for IBS with constipation. The study will enroll 300 patients in the UK, with the first patient expected to be dosed in the second quarter. Thairm Bio and the Scottish National Investment Bank co-led the financing, which was supported by other new and existing investors. — Ayisha Sharma Canada greenlights Dr. Reddy’s Laboratories’ generic semaglutide: The country’s medicines regulator, Health Canada, approved the drug for adults with type 2 diabetes. Semaglutide is the active ingredient in Novo Nordisk’s blockbuster diabetes and weight loss medicines Wegovy and Ozempic. — Ayisha Sharma

Pfizer is edging its BCMA-targeting bispecific Elrexfio (elranatamab) out of the treatment margins and into earlier lines of care, after a new Phase III readout suggests the drug may be able to help hold off disease progression longer than a standard regimen in patients with relapsed/refractory multiple myeloma.Elrexfio was granted an accelerated approval from the FDA in 2023 for use in fifth-line patients, including those who had prior treatment with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The drug is authorised in the EU as well in the fourth-line setting.The decisions were based on Phase II results from the single-arm MagnetisMM-3 trial, which investigated subcutaneous Elrexfio monotherapy in heavily pretreated patients.Among 97 patients who had received at least four prior therapies, the overall response rate was 58%, and about 82% of those maintained their response for at least nine months. A cohort of 64 patients who had already been treated with a BCMA-targeted therapy, such as CAR-T cell therapy or an antibody-drug conjugate, the response rate was lower at 33%. Still, responses had staying pwer, with an estimated 84% lasting at least nine months.PFS 'exceeded' efficacy targetOn Wednesday, Pfizer toplined data from the Phase III MagnetisMM-5 study testing Elrexfio as monotherapy against standard-of-care with Johnson & Johnson's CD38-directed antibody Darzalex (daratumumab) plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients who had received at least one prior line of treatment.The primary endpoint is progression‑free survival (PFS) as assessed by blinded independent central review. "The PFS results exceeded the pre-specified interim analysis target hazard ratio for efficacy, with most ELREXFIO-treated patients remaining progression-free," Pfizer said in a company release.Data for the key secondary goal of overall survival (OS) are still immature, and the trial is ongoing."The MagnetisMM-5 results reinforce our confidence in Elrexfio's potential to benefit patients earlier in their treatment journey," said Jeff Legos, chief oncology officer at Pfizer. The company plans to share the results with global health authorities for potential regulatory submissions.Industry watchers who spoke to FirstWord for a report last year said they were keen on the prospect of moving BCMA-targeting bispecific antibodies like Elrexfio as well as J&J's Tecvayli (teclistamab) to earlier lines, even though they tend to be less effective than the CAR T-cell therapies."We need to be able to use the [bispecific antibodies] in earlier relapse settings…Second-line, I don't know, but third-line for sure we would like to be able to use these and in combination," remarked one US-based key opinion leader (see – KOL Insight - Multiple Myeloma).In March, US regulators granted a speedy approval to a combination of Tecvayli plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) for second-line patients with relapsed or refractory myeloma after impressive data from the Phase III MajesTEC-3 trial showed the combo led to three-year PFS and OS rates exceeding 83% (see – Spotlight On: J&J’s eye-popping MajesTEC-3 data a win for Tecvayli, MM bispecifics and Physician Views In-Depth: US oncologists heavily favour Tecvayli among MM bispecifics).