1. Approval of BRAFTOVI® (encorafenib) combination therapy with chemotherapy by the U.S. FDA

Pfizer announced that the U.S. FDA has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and chemotherapy (mFOLFOX6 - fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. A Phase 3 BREAKWATER trial supported the recent accelerated approval. The trial met its primary endpoint of confirmed overall response rate (ORR). ORR is 61% in the combination therapy arm compared to 40% in the standard-of-care therapy arm. Moreover, the median duration of response (DoR) was 13.9 months for the BRAFTOVI combination regimen versus 11.1 months of standard-of-care treatment.

Link: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-braftovir-combination-regimen-first

2. Prasinezumab did not achieve the primary endpoint in delaying motor progression

Roche announced results from Phase IIb PADOVA study investigating prasinezumab in people with early-stage Parkinson’s disease. Prasinezumab failed to achieve the primary endpoint of time to confirm motor progression. However, the therapy still showed positive trends to prevent disease exacerbation.  Prasinezumab is an investigational monoclonal antibody designed to target aggregated α-syn and reduce neuronal toxicity selectively. The company will continue to monitor the ongoing trial and discuss it together with health authorities.

Link: https://www.roche.com/media/releases/med-cor-2024-12-19

3. Updates from Merck’s license agreements and ongoing studies

Recently, Merck announced the closure of the global license agreement for LM-299, an investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd. On the other hand, they also announced a new global license agreement on an investigational preclinical oral small molecule GLP-1 receptor agonist from Hansoh Pharma. The latest collaboration is to boost Merck’s GLP-1 portfolio, previously, their dual GLP-1/glucagon receptor agonist named efinopegdutide has shown superiority against Ozempic (semaglutide). Moreover, they have also closed KeyVibe program and KEYFORM program investigating vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, respectively. 

Link: https://www.merck.com/news/merck-closes-exclusive-global-license-agreement-for-lm-299-an-investigational-anti-pd-1-vegf-bispecific-antibody/

https://www.merck.com/news/merck-enters-into-exclusive-global-license-agreement-with-hansoh-pharma-for-investigational-oral-glp-1-receptor-agonist/
https://www.merck.com/news/merck-provides-update-on-keyvibe-and-keyform-clinical-development-programs-evaluating-investigational-vibostolimab-and-favezelimab-fixed-dose-combinations-with-pembrolizumab/

4. Duvakitug successfully controlled IBD disease in a phase 2b study

Sanofi and Teva Pharmaceuticals announced that the RELIEVE UCCD phase 2b study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD). The study is investigating duvakitug, a monoclonal antibody targeting TL1A, for treating moderate-to-severe inflammatory bowel disease (IBD). Blocking TL1A can block the downstream inflammation signalling and fibrosis induced by TL1A binding to its receptor, DR3. In the study, 36.2% (low dose) and 47.8% (high dose) of UC patients achieved clinical remission compared to 20.45% on the placebo arm. Moreover, in patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo at week 14.

Link: https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-17-12-30-00-2998154

5. Approval of Zepbound® (tirzepatide) to manage obstructive sleep apnea and obesity

Eli Lilly and Company announced that the U.S. FDA approved Zepbound® (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) and obesity. OSA is a sleep disorder caused by complete or partial collapses of the upper airway during sleep. This approval was supported by results from the SURMOUNT-OSA phase 3 trials, which evaluated the use of Zepbound with and without positive airway pressure (PAP) on OSA and obesity. The drug was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy (25 fewer per hour on Zepbound vs. 5 fewer per hour on placebo). Zepbound also led to 29 fewer breathing disruptions per hour in adults on PAP therapy compared to six with placebo. After one year, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively. In addition, adults on Zepbound lost an average of 45 lbs (18%) of their body weight, while adults on Zepbound with PAP therapy lost an average of 50 lbs (20%) of their body weight, compared to 4 lbs (2%) and 6 lbs (2%) on placebo, respectively.

Link: https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription

6. 8mg aflibercept demonstrated comparable efficacy and tolerability compared to the current 2mg dosage

Bayer announced positive results from the global phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion. The study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy Eylea™ 2 mg (aflibercept 2 mg) every 4 weeks. The new dosage form can provide sustained disease control and is promising to become the new standard of care for this disease.

Link: https://www.bayer.com/media/en-us/aflibercept-8-mg-met-primary-endpoint-in-phase-iii-study-and-demonstrates-vision-gains-with-extended-treatment-intervals-in-retinal-vein-occlusion/

7. Combination of cagrilintide and semaglutide showed superior weight reduction compared to monotherapy

Novo Nordisk announced results from the phase 3 REDEFINE 1 trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo over 68 weeks. Cagrilintide binds to the amylin receptors in the brain, which enhance the feelings of fullness or satiety. The trial achieved its primary endpoint by demonstrating a statistically significant weight loss at week 68 with CagriSema versus placebo. CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone. In addition, 40.4% of patients on CagriSema reached a weight loss of 25% or more, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.

Link: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915082

8. Successful management of SLE by Cenerimod in a Phase 2b trial

Viatris announced Phase 2b CARE results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE). Cenerimod is an investigational and highly selective S1P1 receptor modulator that targets SLE pathogenesis through immunomodulatory effects on lymphocytes, inflammation and antigen transport.  Results showed cenerimod demonstrated clinically meaningful and sustained improvement from baseline of SLE disease activity compared to placebo by improving mSLEDAI-2K score. Moreover, other measurements, such as IFN-1 gene expression and IFN-γ-associated proteins, have also been well-controlled after the treatment.

Link: https://newsroom.viatris.com/2024-12-18-Viatris-Announces-Publication-of-Phase-2b-CARE-Study-Data-for-Cenerimod-in-Lancet-Rheumatology