DAIICHI SANKYO, INC.

The WSG-TP-II trial (NCT03272477) explored de-escalation of neoadjuvant endocrine therapy plus trastuzumab and pertuzumab in HR-positive, HER2-positive early breast cancer. Conducted in Germany, it compared 12 weeks of endocrine therapy or paclitaxel with trastuzumab and pertuzumab, followed by 1 year of adjuvant therapy. The trial found this regimen safe for chemotherapy de-escalation.

Diabetic Peripheral Neuropathy market to surge due to increasing prevalence and awareness, with multiple-stage pipeline products revolutionizing market dynamics. Key companies include Grünenthal, Averitas Pharma, Daiichi Sankyo, Vertex Pharmaceuticals, Helixmith, and Lexicon Pharmaceuticals. Emerging therapies such as QUTENZA (capsaicin) and TARLIGE (mirogabalin besylate) are expected to drive market growth.

Daiichi Sankyo and AstraZeneca's ENHERTU receives conditional approval from China's NMPA for treating unresectable or metastatic NSCLC with HER2 mutations, marking the fourth approval in China for ENHERTU across different tumor types. The approval is based on Phase II studies DESTINY-Lung02 and DESTINY-Lung05, showing ORRs of 49% and 58.3% respectively.

AstraZeneca and Daiichi Sankyo's Enhertu received conditional approval in China for treating HER2-mutant metastatic NSCLC, based on DESTINY-Lung02 and DESTINY-Lung05 trials. Enhertu demonstrated a confirmed objective response rate of 49.0% in DESTINY-Lung02 and 58.3% in DESTINY-Lung05, with no new safety concerns. This marks the first HER2-directed therapy approved in China for this indication.

AstraZeneca's Enhertu receives approval in China as the first HER2-directed therapy for HER2-mutant metastatic non-small cell lung cancer, based on phase 2 trial results. This marks the fourth approval in China for Enhertu, co-developed with Daiichi Sankyo, across three different tumor types.

Daiichi Sankyo boosts production of newer-generation cancer therapies, including antibody drug conjugates (ADCs), across Japan, Europe, and the US. The ADCs, likened to guided missiles targeting cancerous cells, have potential to replace chemotherapy. Daiichi Sankyo partners with AstraZeneca and Merck & Co. for ADC development, with Enhertu on track for over $3.4 billion in revenue this fiscal year.

The World Companion Diagnostics & Liquid Biopsy Summit APAC, Nov 13-14, 2024 in Singapore, brings together experts to discuss NGS, biomarker development, and clinical trial assay advancements. The event offers networking, insights, and discussions on regulatory guidelines, market access, and novel technologies for precision medicine.

Adcendo’s antibody-drug conjugate (ADC) candidate, ADCE-D01, targeting uPARAP, received FDA IND clearance for a Phase I/II study in metastatic soft tissue sarcoma. The study aims to assess safety, tolerability, and efficacy, with plans for patient recruitment in the US and Europe.

Oncolytics Biotech seeks accelerated approval for pelareorep, its lead cancer therapy, based on positive Phase II BRACELET-1 trial data. A registrational Phase II trial is planned for 2025, evaluating pelareorep combined with paclitaxel in breast cancer patients. Oncolytics' stock rose 18.22% on the news, reflecting investor optimism. Oncolytic virus therapies are projected to see significant growth, from $114m in 2023 to $2.4bn by 2029.