March 4th Week, 2025 Regulatory Events 🎯 CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) ❓ How do sugemalimab’s outcomes compare with those of previously approved AstraZeneca’s durvalumab? Special Designations ⭐ Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has

March 2nd Week, 2025 Mergers & Acquisitions 🤝 Checkpoint Therapeutics Inc is set to be acquired by SUN PHARMA, an Indian pharma giant. This deal will strengthen Sun Pharma’s onco-dermatology portfolio, as it includes Unloxcyt (cosibelimab-ipdl), an FDA-approved anti-PD-L1 treatment indicated for advanced cutaneous squamous cell carcinoma (cSCC) (Ref 1) ❓ How will this acquisition position Sun Pharma in the immuno-oncology space? What is the indication expansion strategy for

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

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

February 3rd Week, 2025 📝With the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMS’ nivo + platinum-doublet CT became the first neoadjuvant-only Tx to significantly improve OS in resectable NSCLC patients. (Ref 1) ❓Will the positive OS data support BMS’ regimen in tackling the competitive threat from the perioperative chemo-IO regimens? 📝The US FDA will be assessing BI's NDA of zongertinib (irreversible ERBB2 TKI) for previously treated, HER2+ve, unres

May 1st & 2nd Week, 2025 ⭐ Deals & Collaborations 🤝 NKure Therapeutics and CRISPR Therapeutics partnered to co-develop CRISPR’s CTX112 (an allogeneic, anti-CD19 CAR-T) for the treatment of R/R B-cell malignancies in India. NKure plans to seek the CDSCO approval by Jun’25 to begin Ph2 trials in India (Ref 1) ❓ What is the competitive landscape of CAR-Ts in India? 🤝 Chong Kun Dang Pharm. acquired a 7.3% stake in AbClon, and received priority rights to commercialize nespecab

April 2nd April, 2025 ⭐ Regulatory Events 🎯 The US FDA cleared an IND application of CERo Therapeutics, Inc.’s CER-1236 (anti-Tim-4L chimeric engulfment receptor T-cell (CER-T)) for a Phase 1 trial in advanced solid tumors specifically NSCLC and ovarian cancer (Ref 1) ❓ What is the difference between CER-T and CAR-Ts and what benefits do CER-Ts offer? ⭐ Setbacks 🛑 Carisma Therapeutics paused R&D activities and is exploring strategic alternatives to maximize value, incl

February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for treating Relapsed or Refractory Large B-cell Lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (Ref 1) ❓ What new evidence led NICE to overturn its initial rejection of Breyanzi in Oct 2024? 📝 Anixa Biosciences received the approval to amend Ovarian Cancer Phase 1/NCT05316129 trial, allowing a second dose of FS

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met primary endpoint of ORR and key secondary endpoint of CRR in marginal zone lymphoma (MZL) cohort. Detailed results will be presented at an upcoming conference (Ref 1, 2) ❓ What are the current benchmarks in MZL? 📝 Imugene’s Azer-cel (an allogeneic, anti-CD19 CAR-T) + low dose IL-2 elicited two additional complete responses resulting in a CRR o

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊 Jazz Pharmaceuticals and BeiGene's zanidatamab (Ziihera; dual HER2-targeted BsAb) monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2+ve biliary tract cancer previously treated with at least one prior line of systemic therapy ⭐ New Biosimilars 💊 CuraTeQ Biologics' trastuzumab (Dazublys; HER2 inhibitor) is indicated for the treatment of HER2+ve metastat

Highlights from the CHMP March 2025 Meeting are out! ⭐ Indication Expansions: 💊 Pfizer's bosutinib (Bosulif; second-generation BCR-ABL TKI) use is extended to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form (hard capsules), associated with two new strengths (50 mg and 100 mg). 💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + rituximab (anti-CD20 mAb) + bendamustine for the Tx of adult pati

Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space: ⭐ New Therapies: 👉 Regeneron's linvoseltamab (BCMA x CD3 BsAb) mono for the treatment of adult patients with R/R multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38, and have demonstrated disease progression on the last therapy ⭐ Indication expansions: 👉 AstraZeneca's acalabru

Welcome to the May edition of our CGT Watch newsletter! CARsgen’s satri-cel priority review & Ph2 results; Autolus’ obe-cel positive CHMP opinion; BrainChild Bio’s BCB-276 RMAT; Gilead & Arcellx’s anito-cel Ph2 updated results; Senti Bio’s SENTI-202 updated Ph1 results; CARsgen’s CT0596 first-time Ph0 results; Artiva Bio’s AlloNK long-term Ph1/2 results; NeoImmuneTech’s NT-17 + CAR-T Ph1 topline results; Nkure and CRISPR Therapeutics partnership; Chong Kun Dang & AbClon part

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