Shots: 

• The 43rd Annual J.P. Morgan Conference took place from 13th to 16th January in San Francisco, USA. J.P. Morgan Healthcare Conference serves as a pioneering hub that features presentations and dialogues on the advances of the healthcare industry by bringing healthcare professionals, researchers, manufacturers, and other healthcare stakeholders to one platform.  
• Innovation remained the focal point in almost every single presentation. Companies shared strategies to tackle LOE and competition along with data readouts from pivotal clinical trials. 
• Reach out to us at connect@pharmashots.com with the subject line “JPM 2025” for the complete report.  

Merck

• In 2025, the company expects approval of Keytruda (SC) with berahyaluronidase alfa and patritumab deruxtecan (HER3-DXd ADC) for which the FDA issued CRL in Jun 2024 
• Furthermore, key findings from the clinical study of Keytruda + CT in earlier stage head and neck squamous cell carcinoma are also anticipated in 2025 
• Merck also highlighted a diverse pipeline of 20 potential new growth drivers, most of which have blockbuster potential 
• Merck highlighted various milestones achieved in 2024:
  1. Keytruda received approvals for advanced cancers such as cervical cancer, endometrial carcinoma and malignant pleural mesothelioma 
  2. The SC formulation of Keytruda with berahyaluronidase alfa depicted positive results  
  3. Keytruda also showed positive outcomes in certain patients with earlier stage cancers such as head and neck squamous cell carcinoma & muscle-invasive urothelial carcinoma, with OS results from renal cell carcinoma, triple-negative breast cancer & FIGO 2014 stage III-IVA cervical cancer studies 

Pfizer

• Pfizer’s acquisition of Seagen doubled its oncology R&D capabilities, making it the third-largest oncology company in the US 
• Key assets include CDK4 for 1L treatment (P-III started), ADCs like SV targeting IB6 (expressed in 90% of NSCLC cases) and PD-L1 for lung and head/neck cancers, and ELREXFIO, which has shown durable responses in multiple myeloma 
• SV is an ADC targeting IB6 protein highly expressed in cancers, especially in 90% of NSCLC. Using vedotin as its payload, SV has shown promising early data. Initial studies began in 2L NSCLC, with 1L trials starting soon. Development is also underway for head and neck cancers due to high IB6 expression 
• For 2L treatment, Pfizer has PF-07248144 in its portfolio, currently being evaluated in P-I for metastatic breast cancer 

Novartis

Novartis presents its oncology portfolio with anchor brands like Kisqali, Scemblix, Pluvicto & Fabhalta, plus future milestones   

• To boost its portfolio against prostate cancer, Novartis’ JSB462 (AR degrader) is advancing into P-II from P-I/II trial in 2025 
• Multiple Next-gen CDK assets are going to enter clinical studies (P-I) in 2025 
• Kisqali for Breast Cancer
  1. Kisqali + oral selective estrogen receptor degraders combination is in P-I/II (sponsored by Olema Pharmaceuticals) & is going to advance into P-III 
  2. Kisqali + mutant-selective PI3Ka inhibitors combination is in P-I/II (sponsored by Scorpion Therapeutics) & is going to advance into the P-II trial 
• Pluvicto For Prostate Cancer 
  1. Novartis filed for Pluvicto pre-taxane label expansion in mCRPC based on recent data from P-III (PSMAfore) trial with approval expected in H1’25 
  2. Pluvicto is in 2 P-III (PSMAddition & PSMA-DC) trial for mHSPC & oligometastatic PC with readout expected in H2’25 & 2027, respectively  
• Radioligand Therapy (RLTs) for Multiple Solid Tumors 
  1. In RLTs, findings of the P-II trial of Lu-NeoB will be announced in 2026 
  2. Ac-PSMA-617 (AAA817; 1st gen α-emitting PSMA RLT) will enter P-III in 2025 while findings of P-I/II of Ac-PSMA-R2 (2nd gen α-emitting PSMA RLT) will be reported in 2026 
  3. Lutathera will enter P-III in 2027 as a potential treatment for ES-SCLC & results of AAA614 (P-I/II) are expected to be announced in 2026  

AstraZeneca

• AZ highlighted the successful completion of the P-III trial evaluating Tagrisso in the LAURA study for patients with unresectable, Stage III EGFR-mutated lung cancer 
• The company highlighted the positive results from the ECHO P-III trial evaluating Calquence + bendamustine + rituximab (now approved) for the treatment of adults with previously untreated MCL 
• AZ unveils +ve results from P-III AMPLIFY study evaluating Calquence + Venetoclax vs. SOC 
• Highlighting +ve results from the P-III DESTINY-Breast06 study, AstraZeneca’s Enhertu demonstrated clinically meaningful PFS in patients with HR-positive, HER2-low metastatic Breast Cancer 
• The company highlighted clinically meaningful results from the P-III CAPItello-281 study evaluating Truqap combination in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) 
• AZ highlighted the +ve results from the P-III ADRIATIC study evaluating Imfinizi for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) 
• The company highlighted clinically meaningful improvement in EFS and OS from the P-III NIAGARA study evaluating Imfinizi + CT vs. neoadjuvant CT in patients with muscle-invasive bladder cancer (MIBC) 
• AZ anticipates +ve results from the ongoing P-III studies evaluating Datroway in the AVANZAR and TROPION-Breast-02 studies, ENHERTU in DESTINY-Breast 09,-11, -05, Imfinizi in VOLGA, POTOMAC, and NILE, Camizestrant in SERENA-6, and Ceralasertib in LATIFY studies  
• AZ shared a glimpse of anticipated P-I/II data readout in 2025 for NMEs with $5B + Peak Year Revenue potential including assets like rilvegostomig (lung, BTC, others) and volrustomig (lung, others) 

For the complete report, reach out to us at connect@pharmashots.com