July 1, 2024 - 🧬 [nGram] Today’s Oncology Scoop: BALVERSA® & RYBREVANT® Get EU Nod, SCG Cell Therapy FDA IND Clearance


  1. 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.
    Read more

  2. 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.
    Read more

  3. 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.
    Read more

  4. 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.
    Read more

  5. 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.
    Read more

  6. 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.
    Read more

  7. 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.
    Read more

  8. 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.
    Read more

  9. 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, IMTACâ„¢.
    Read more

  10. 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.
    Read more