May 5th Week, 2025 Regulatory Events 🎯 The EC approved Bristol Myers Squibb’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1) co-formulated with Halozyme, Inc.’s recombinant human hyaluronidase (rHuPH20) for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab + ipilimumab IV, or in combination with chemotherapy or cabozantinib. (Ref 1) ❓ What is the development status of other key subcutaneous immune checkpoint

May 4th Week, 2025 Regulatory Events 🎯 The US FDA granted a Fast Track designation to CSPC Pharmaceutical Group ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1) ❓ Which other ADCs are being developed for this setting? 🎯 Zai Lab's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients

April 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc