September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company's imlunestrant (oral estrogen receptor antagonist) for the Tx of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 Nuvalent, Inc., completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine

August 4th Week, 2025 Regulatory Events 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + platinum-containing chemo as neoadjuvant Tx followed by tislelizumab monotherapy as adjuvant Tx for resectable NSCLC at high risk of recurrence. (Ref 1) ❓ How is BeOne’s regimen positioned compared to other approved perioperative options? Clinical Events 🔬 Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benef

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

July 3rd Week, 2025 Regulatory Updates 🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer. (Ref 1) ❓ What are the clinical outcomes that support the NDA submission? Special Designations ⭐ The US FDA granted the Priority Review to Johnson & Johnson Innovative Medicine’s TAR-200 (intravesical gemcitabine releasing system) for the Tx of BCG unresponsive high-risk non-

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC (Ref) The first patient has been successfully enrolled in the registration Phase 3 AK112-312/HARMONi-GI6 trial of Akeso and Summit's ivonescimab (PD-1 x VEGF BsAb) in first-line treatment for advanced metastatic colorectal cancer (mCRC) The trial is evaluating ivonescimab + FOLFOXIRI vs bevacizumab + FOLFOXIRI Primary completion date: Jan'27

22/06/2025 The Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab achieved significant OS benefit in metastatic colorectal cancer (Ref) Per topline results from the Phase 3 STELLAR-303/NCT05425940 pivotal trial, Exelixis' zanzalintinib (third-generation oral tyrosine kinase inhibitor) + Roche's atezolizumab (aPD-L1) demonstrated a statistically significant improvement in OS vs regorafenib in previously treated, non-microsatellite instability (MSI)-high metastatic color

April 2nd Week, 2025 Regulatory Events 🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1) ❓What is the status of trastuzumab deruxtecan for these patients in other key markets? 🎯AstraZeneca and D

April 3rd & 4th, 2025 Regulatory Updates 🎯 The UK MHRA granted conditional marketing authorization for Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult R/R B-ALL patients based on the results from the Ph1/2 FELIX/NCT04404660 study (Ref 1) ❓ In what ways does Aucatzyl’s fast off-rate CD19 binding domain differentiate it from existing CD19 CAR-Ts for B-ALL? 🎯 Lyell Immunopharma received RMAT designation f

24/04/2025 Ivonescimab Plus Chemotherapy Shows Statistically Significant Superiority Over Tislelizumab in First-Line Treatment of Squamous NSCLC (Ref 1) Akeso and Summit Therapeutics' ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), in combination with chemotherapy, met its primary endpoint of progression-free survival (PFS) in the Phase 3 HARMONi-6 trial versus tislelizumab (anti-PD-1) + chemotherapy as a first-line treatment of advanced, squamous non-small cell lung can