CHMP adopts positive opinion for Balversa (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Pending approval, erdafitinib would be the first therapy targeting FGFR3 alterations in metastatic urothelial carcinoma.
- The CHMP’s recommendation is based on results from Cohort 1 of the Phase 3 THOR study, showing a 36% reduction in the risk of death with erdafitinib versus chemotherapy.
- Erdafitinib is recommended as a once-daily oral monotherapy for patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor.
- The THOR study demonstrated a median overall survival of 12.1 months for erdafitinib compared to 7.8 months for chemotherapy.
- Serious treatment-related adverse events were observed in 13.3% of patients on erdafitinib versus 24.1% on chemotherapy.
- Next steps include awaiting final approval to provide eligible patients with a new treatment option across the region.
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Rybrevant in combination with chemotherapy approved by European Commission for first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations
- The European Commission (EC) has approved Rybrevant (amivantamab) in combination with chemotherapy for first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
- Approval is based on the Phase 3 PAPILLON study, which showed a 60% reduction in the risk of disease progression or death compared to chemotherapy alone.
- The study demonstrated a significant improvement in progression-free survival (PFS) with a hazard ratio of 0.395.
- The safety profile of the combination was consistent with the individual agents, with low rates of treatment-related discontinuation.
- The conditional marketing authorization for amivantamab, received in December 2021, has been converted to a standard marketing authorization.
- Next steps include potential regulatory actions in other geographies and further studies on amivantamab in combination with other therapies.
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Significant tumor reductions in neoadjuvant MSS colon cancer patients treated with botensilimab/balstilimab presented at ESMO GI conference
- Agenus Inc. announced results from an investigator-sponsored trial of botensilimab and balstilimab in neoadjuvant colon cancer.
- The trial included 20 patients, with 17 being microsatellite stable (MSS) and 3 having high microsatellite instability (MSI-H).
- In the NEST-2 cohort, 78% of MSS patients achieved at least 50% tumor regression, with 56% reaching complete pathologic responses.
- No surgeries were delayed due to adverse events, and side effects were manageable with no new safety concerns.
- The study highlights the potential of BOT/BAL therapy to minimize disease recurrence and reduce the need for invasive procedures and chemotherapy.
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SCG Cell Therapy announces FDA IND clearance of SCG142, a next-generation HPV-specific TCR T cell therapy for patients with HPV-associated solid tumors
- SCG Cell Therapy received FDA IND approval to initiate Phase 1/2 clinical trial for SCG142.
- SCG142 is a novel HPV E7-specific TCR T cell therapy targeting HPV-associated solid tumors.
- The therapy uses a high-avidity fully natural HPV-specific TCR with a TGFβRII-41BB chimeric switch receptor.
- Preclinical data presented at ASGCT 2024 showed high polyfunctional avidity and favorable safety profile.
- SCG142 demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor inhibition in vitro and in vivo.
- The trial will assess the potential benefits of SCG142 in overcoming the hostile tumor microenvironment.
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Iovance Biotherapeutics submits marketing authorization application to European Medicines Agency for lifileucel in advanced melanoma
- Iovance Biotherapeutics has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel.
- Lifileucel is a TIL cell therapy for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody.
- If approved, lifileucel will be the first and only approved therapy in this treatment setting in all EU member states.
- The MAA submission is supported by positive clinical data from the C-144-01 clinical trial in advanced post-anti-PD1 melanoma patients.
- The Committee for Medicinal Products for Human Use (CHMP) is expected to issue a scientific opinion in 2025.
- Additional marketing submissions for lifileucel are planned in Canada and the UK in the second half of 2024, and in Australia in 2025.
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SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
- SpringWorks Therapeutics has submitted a New Drug Application (NDA) to the FDA for mirdametinib, an investigational MEK inhibitor.
- The NDA submission is for the treatment of pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).
- Data from the pivotal Phase 2b ReNeu trial, which showed significant objective response rates and a manageable safety profile, supports the NDA.
- The FDA and the European Commission have granted Orphan Drug designation for mirdametinib, and the FDA has also granted Fast Track and Rare Pediatric Disease designations.
- SpringWorks plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2024.
- The ReNeu trial enrolled 114 patients and evaluated mirdametinib's efficacy, safety, and tolerability in patients aged ≥ 2 years with inoperable NF1-associated PN.
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Odronextamab recommended for EU approval by the CHMP to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
- The CHMP has recommended conditional marketing authorization for odronextamab to treat adults with relapsed/refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
- The recommendation is based on data from Phase 1 and pivotal Phase 2 trials showing robust and durable response rates.
- FL and DLBCL are the most common subtypes of B-cell non-Hodgkin lymphoma, with significant relapse rates after initial treatments.
- The Phase 1 ELM-1 and Phase 2 ELM-2 trials demonstrated an acceptable safety profile, with common serious adverse reactions including cytokine release syndrome, pneumonia, COVID-19, and pyrexia.
- Odronextamab has Orphan Designation for both FL and DLBCL and is currently under clinical development.
- Regeneron is also evaluating odronextamab in combination therapies and in earlier lines of treatment through various clinical programs.
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Epcoritamab receives positive CHMP opinion for relapsed/refractory follicular lymphoma
- Epcoritamab (TEPKINLY) received a positive opinion from the EMA's CHMP for treating adults with relapsed/refractory follicular lymphoma (FL).
- The recommendation is based on results from the Phase 1/2 EPCORE NHL-1 study.
- If approved, it will be the first bispecific antibody conditionally approved as a monotherapy in the EU for both relapsed/refractory FL and DLBCL.
- The EPCORE NHL-1 trial showed an overall response rate with common adverse reactions including CRS, injection site reactions, and neutropenia.
- An optimized step-up dosing schedule was evaluated to reduce the incidence and severity of CRS.
- The final decision from the European Commission is anticipated later this year.
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BridGene Biosciences announces dosing of first patient in phase 1 study evaluating novel TEAD inhibitor BGC515 in advanced solid tumors
- BridGene Biosciences has dosed the first patient in its Phase 1 clinical trial of BGC515, a novel TEAD inhibitor.
- The trial will enroll subjects in both the US and China to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
- BGC515 targets TEAD proteins, a critical component in the Hippo signaling pathway, and is aimed at treating advanced solid tumors.
- The study includes patients with malignant mesothelioma, epithelioid hemangioendothelioma, and other solid tumors with Hippo pathway dysregulation.
- Dr. Timothy Yap from the University of Texas MD Anderson Cancer Center is the principal investigator at the initial US site.
- BGC515 is an orally-administered, covalent TEAD inhibitor developed through BridGene's chemoproteomic platform, IMTAC™.
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OSE Immunotherapeutics publishes preclinical efficacy results with lusvertikimab in acute lymphoblastic leukemia
- OSE Immunotherapeutics announced the publication of preclinical efficacy data on Lusvertikimab in the journal 'Blood'.
- The study was a collaborative effort with the University Medical Center Schleswig-Holstein in Kiel, Germany.
- Lusvertikimab targets and blocks high IL-7R expression in B- and T-Cell Acute Lymphoblastic Leukemia (ALL) patients.
- The drug works through dual mechanisms: blocking IL-7 receptor signaling and inducing antibody-dependent cellular phagocytosis.
- Preclinical models showed significant in vivo efficacy using patient-derived samples and xenograft models.
- Lusvertikimab could potentially improve therapy outcomes for relapsed/refractory ALL patients when combined with standard polychemotherapy.
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