1. Approval of Opdivo plus Yervoy for colorectal cancer by the European Commission
On December 23, 2024, BMS announced that the European Commission has approved Opdivo® (nivolumab, PD-1 inhibitor) plus Yervoy® (ipilimumab, CTLA-4 inhibitor) as the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). The approval is based on results from a Phase 3 CheckMate -8HW trial, where Opdivo plus Yervoy improved the dual primary endpoints of progression-free survival (PFS) and reduced the risk of disease progression or death by 79% compared to the investigator’s choice of chemotherapy.
2. Positive topline results from two Phase 3 trials evaluating Sotyktu on psoriatic arthritis
On December 23, 2024, BMS announced two Phase 3 trial results - POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials have met their primary endpoints, more patients in the treatment arm showed at least 20% improvement in signs and symptoms of diseases compared to the placebo group. Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, inhibiting signaling of IL-23, IL-12 and Type 1 IFN, key cytokines involved in the pathogenesis of multiple immune-mediated diseases.
The results represent the first Phase 3 clinical trials for Sotyktu in a rheumatic condition, previously, it was approved for treating adults with moderate-to-severe plaque psoriasis.
3. U.S. FDA approves the subcutaneous dosage form of Opdivo for solid tumors
form of On December 27, 2024, BMS announced the approval of Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) subcutaneous injection dosage by the U.S. FDA. It is a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20). The approval is supported by a Phase 3 CheckMate-67T trial, where subcutaneous dosage showed non-inferior pharmacokinetic exposure, similar efficacy and comparable safety to the intravenous dosage. The trial's co-primary endpoints were time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo. The geometric mean ratios (GMRs) for Cavgd28 was 2.10 and the GMR for Cminss was 1.77. As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% compared with 18% in the IV Opdivo arm (n=247), showing similar efficacy of these two products. With the new approval, Opdivo Qvantig offers a faster delivery for patients in three to five minutes compared to 30-minute IV infusion.
4. Approval of Tagrisso (osimertinib) for NSCLC in Europe
On December 23, 2024, AstraZeneca announced that Tagrisso (osimertinib) has been approved in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). The approval followed the recommendation from CHMP and was supported by the Phase 3 LAURA trial. In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. However, Overall survival (OS) results remain immature, and the trial continues to assess OS as a secondary endpoint.
5. Voluntary withdrawal of datopotamab deruxtecan (Dato-DXd) market application in the EU
On December 24, 2024, AstraZeneca and Daiichi Sankyo voluntarily withdrew the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Datopotamab deruxtecan is a engineered TROP2-directed DXd antibody drug conjugate. The decision to withdraw the MAA was informed by the CHMP of the European Medicines Agency (EMA) based on current data from the TROPION-Lung01 Phase III trial. The trial results revealed that the drug did not significantly improve overall survival for patients.
Link: https://www.astrazeneca.com/media-centre/press-releases/2024/dato-dxd-nsq-nsclc-application-withdrawn-in-eu.html;
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202412/20241224_E.pdf;
https://www.business-standard.com/companies/news/astrazeneca-withdraws-datopotamab-deruxtecan-ema-lung-cancer-124122400548_1.html
6. Apporval of DATROWAY® (datopotamab deruxtecan) in Japan to treat breast cancer
Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. DATROWAY is the first ever TROP-2 directed medicine to be approved in Japan for HR positive, HER2 negative breast cancer. The approval is based on results from the TROPION-Breast01 phase 3 trial, where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to the investigator’s choice of chemotherapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in other regulation authorities.
Link: https://www.daiichisankyo.com/files/news/pressrelease/pdf/202412/20241227_E.pdf
7. Approval of subcutaneous injection of HYQVIA® 10% in Japan
Takeda announced that the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with agammaglobulinemia or hypogammaglobulinemia caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID) has been approved. Subcutaneous infusion allows a larger infusion volume to increase administration flexibility and decrease the dosing frequency. The approval is based on data from two pivotal Phase 3, open-label, non-controlled studies evaluating Japanese subjects’ efficacy, safety, tolerability and pharmacokinetics. The Geo Mean of IgG trough level at the last 3 visits was 9.494g/L and was maintained at level comparable to treatment with intravenous or subcutaneous immunoglobulin.
8. BeiGene announced that the U.S. FDA approved TEVIMBRA® (tislelizumab-jsgr),
BeiGene announced that the U.S. FDA approved TEVIMBRA® (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with PD-L1 positive tumors. The additional indication approval is based on results from the randomized, double-blind, placebo-controlled, global Phase 3 RATIONALE-305 trial. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with the investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy. It leads to a 20% reduction in the risk of death. An additional Biologics License Application (BLA) is under review at the FDA for the first-line treatment of adult patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
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