Media Update: Rezurock® (belumosudil) patient-reported outcomes correlated with clinical response in chronic graft-versus-host disease

Rezurock ® (belumosudil) p atient- r eported o utcomes c orrelated with c linical r esponse in c hronic g raft- v ersus- h ost d isease Results demonstrate strong, but not universal, correlation between organ clinical responses and clinically meaningful improvements in patient-reported outcomes from a pooled analysis of ROCKstar and KD025-208 clinical trials Paris , April 21, 2022. Results from a pooled analysis of Rezurock ® (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD) show certain organ clinical responses correlated with clinically meaningful changes in patient-reported outcomes (PROs). Kadmon, a Sanofi Company, will present the results at the 2022 American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) Tandem Meetings in Salt Lake City, Utah. Jonathan Ieyoub Head of Sanofi US Rezurock Medical “These Rezurock data reinforce the importance of patient-reported outcome measures by showing their correlation to clinical response . Knowing the impact that chronic graft-versus-host disease has on patients, the results add support for use of patient-reported outcomes to assess responses in clinical care.” The pooled analysis of the ROCKstar (KD025-213) and KD025-208 studies demonstrates a very strong, but not universal, correlation between organ clinical response measures and clinically meaningful changes in PROs in patients treated with Rezurock. In particular, the clinically meaningful changes in PROs were reported in the skin, mouth, eye, upper GI, lung (clinical lung scale score), and overall measures. These data support use of PROs for response assessment in cGVHD clinical trials and patient care to help capture the patient’s perspective on cGVHD disease activity. About the Pooled Analysis The pooled analysis of clinical and PRO data included 170 (91.3%) patients enrolled in two Rezurock studies (n=132, KD025-213; n=54, KD025-208) who had baseline PROs, at least one follow-up PRO, and at least one response assessment. The median age was 54.5 years, 98 (58%) were men, the median number of prior treatments was 3, 70% had severe cGVHD, and the median duration of follow-up at the time of data cut-off was 15 months (range, 0.6-44 months). Organ responses, defined as complete responses (CR) and partial responses (PR), were 35% (48/135) in skin, 68% (84/124) in joints, 57% (56/99) in mouth, 41% (52/128) in eyes, 73% (19/26) in upper GI, 87% (13/15) in lower GI, 23% (14/61) in lungs, and 77% (130/170) overall. For all organs except for joints, oesophagus, and lower GI there was at least one PRO that was statistically correlated at p<0.05 with National Institutes of Health (NIH) organ response. NIH clinical lung response, but not the lung response based on FEV1% change, was associated with the lung PRO. Correlation of NIH organ response (CR+PR) with clinically meaningful patient-reported outcomes (PROs) Organ Response measure Clinically meaningful change Patient-reported outcome Clinically meaningful change OR, 95% CI, for improvement in PRO predicting NIH response p-value Skin NIH Skin score [0-3] 1 pt LSS skin scale [0-100] 11 pts 2.16 (1.12-4.16) 0.021 Sclerotic skin [0-10] 2 pts LSS skin scale [0-100] 11 pts 1.66 (0.91-3.01) 0.098 Sclerotic skin [0-10] 2 pts S kin tightening [0-10] 2 pts 2.50 (1.28-4.87) 0.007 Joint P-ROM [4-25] 2 pts LSS single item joints [0-4] 1 pt 1.49 (0.84-2.66) 0.175 NIH joint score [0-3] 1 pt LSS single item joints [0-4] 1 pt 1.26 (0.73-2.20) 0.408 Mouth Oral mucositis rating scale 2 pts LSS mouth scale [0-100] 13 pts 6.36 (2.94-13.74) <0.0001 Oral mucositis rating scale 2 pts M outh sensitivity [0-10] 2 pts 4.53 (2.25-9.09) <0.0001 GI NIH esophagus score [0-3] 1 pt LSS nutrition scale [0-100] 7 pts 1.32 (0.53-3.29) 0.546 NIH upper GI score [0-3] 1 pt LSS nutrition scale [0-100] 7 pts 4.44 (1.74-11.35) 0.002 NIH lower GI score [0-3] 1 pt LSS nutrition scale [0-100] 7 pts 0.91 (0.27-3.05) 0.878 Eye NIH eye score [0-3] 1 pt LSS eye scale [0-100] 15 pts 3.39 (1.98-5.82) <0.0001 NIH eye score [0-3] 1 pt Worst eye compliant [0-10] 2 pts 2.35 (1.33-4.15) 0.003 Lung FEV1% 10% LSS lung scale [0-100] 8 pts 0.90 (0.43-1.87) 0.779 NIH lung score [0-3] 1 pt LSS lung scale [0-100] 8 pts 2.81 (1.70-4.65) <0.0001 Overall NIH responder [CR+PR] vs. nonresponder LSS summary scale [0-100] 7 pts 1.89 (1.17-3.06) 0.010 NIH responder [CR+PR] vs. nonresponder O verall cGVHD [0-10] 2 pts 2.37 (1.48-3.77) <0.001 Overall severity [0-10] 2 pts LSS summary scale [0-100] 7 pts 1.84 (1.08-3.11) 0.024 Overall severity [0-10] 2 pts O verall cGVHD [0-10] 2 pts 3.46 (2.17-5.52) <0.0001 Pt, point; LSS, Lee symptom scale; GI, gastrointestinal; P-ROM, photographic range of motion About cGVHD cGVHD is a complication that can occur following allogeneic stem cell transplantation, resulting in significant morbidity and mortality. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, oesophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are living with cGVHD. About Rezurock ® (belumosudil) Rezurock ® (belumosudil) is the first and only approved therapy inhibiting Rho-associated coiled-coil kinase 2 (ROCK2). Rezurock is approved in the United States for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. For more information, visit www.Rezurock.com . About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sally Bain | + 1 617 834 6026 | [email protected] Kate Conway | + 1 508 364 4931 | [email protected] Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | [email protected] Arnaud Delépine | + 33 6 73 69 36 93 | [email protected] Corentine Driancourt | + 33 6 40 56 92 21 | [email protected] Felix Lauscher | + 1 908 612 7239 | [email protected] Priya Nanduri | +1 908 981 5560 | [email protected] Nathalie Pham | + 33 7 85 93 30 17 | [email protected] Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. 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