Natera, Inc. · NASDAQ:NTRA
Natera — Technical Presentation (January 2022)
20 slides from Natera's technical presentation, Jan 24, 2022
Slide 1: Natera, Inc. ASCO GI Symposium - data review
Natera, Inc. ASCO GI Symposium - data review January 24, 2022
Slide 2: Safe harbor statement
Safe harbor statement This presentation contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our p
Slide 3: Update from ASCO GI Symposium, Jan 2022
Update from ASCO GI Symposium, Jan 2022 ● New predictive data in CRC from CIRCULATE Japan – the largest prospective MRD study ⎼ Signatera-positive post surgery: benefit significantly from adjuvant chemo ⎼ Signatera-negative post surgery: no significant benefit from adjuvant chemo ⎼ Signatera ctDNA c
Slide 4: Why predictive data matters
Why predictive data matters • Lack of predictive data has been a barrier to Adjuvant Therapy for Stage II Colon Cancer: adoption into guidelines and clinical practice ASCO Guideline Update, December 2021 “ctDNA was identified as an emerging potential predictive factor; however, • Unproven until now:
Slide 5: Circulate-IDEA Japan: largest prospective MRD study
Circulate-IDEA Japan: largest prospective MRD study 2021: ESMO GI1 2022: ASCO-GI2 • ~1200 patients enrolled • ~3000 patients enrolled • ~800 patients analyzed • ~1000 patients analyzed • Disease free survival stratified • Disease free survival stratified by MRD by MRD status: status and by treatment
Slide 6: DFS from single timepoint at 4 weeks post surgery (pStage II-III)
DFS from single timepoint at 4 weeks post surgery (pStage II-III) % 100 ctDNA Negative 80 Positive 60 DFS 40 ctDNA Events/N 6M-DFS (95%CI) 12M-DFS (95%CI) HR = 13.3 Negative 22/597 97.8% (96.3-98.7) 95.2% (92.6–96.9) 95% CI, 8.0 to 22.2, P<0.001 20 Positive 46/115 73.0% (63.9-80.2) 55.5% (44.8–65.0)
Slide 7: New predictive data
New predictive data Disease-free survival (DFS) Key questions % MRD-negative 100 80 MRD-positive 60 Do MRD-positive patients benefit from chemo? ► across all stages of disease? 40 20 0 0 6 12 18 Months after surgery Kotaka et al. Association of circulating tumor DNA dynamics with clinical outcomes i
Slide 8: MRD-positive patients benefit significantly from ACT
MRD-positive patients benefit significantly from ACT DFS in post-op-4w MRD-positive population % High-risk pStage II % pStage III % pStage IV 100 100 100 W/ ACT 80 80 80 W/O ACT 60 60 60 DFS 40 40 40 20 20 20 Adjusted HR = 9.4 Adjusted HR = 8.8 Adjusted HR = 2.4 95% CI, 1.1 to 79.1, P=0.04 95% CI, 3
Slide 9: New predictive data
New predictive data Disease-free survival (DFS) Key questions % MRD-negative 100 Do MRD-negative patients benefit from chemo? 80 MRD-positive 60 40 20 0 0 6 12 18 Months after surgery Kotaka et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patie
Slide 10: No significant treatment benefit for MRD-negative patients
No significant treatment benefit for MRD-negative patients DFS in post-op-4w MRD-negative population (High risk stage II-III) % 100 W/ ACT W/O ACT 80 60 DFS 40 ctDNA Events/N 6M-DFS (95%CI) 12M-DFS (95%CI) W/ ACT 7/214 98.6% (95.7-99.5) 96.2% (92.1–98.2) Adjusted HR = 1.3 20 W/O ACT 12/317 97.5% (95
Slide 11: Analyzing ctDNA clearance
Analyzing ctDNA clearance Surgery 4w 12w Chemo à • Does the MRD status change between 4w to 12w? (positive/negative) • Does the change correlate with outcome, and can ctDNA clearance predict treatment benefit? (i.e., surrogate endpoint) 11 Not for reproduction or further distribution.
Slide 12: ctDNA clearance is predictive
ctDNA clearance is predictive DFS by ctDNA dynamics from post-op-4w to 12w % Neg > Neg 100 Dynamics Neg > Neg Neg > Pos Pos > Neg Pos > Pos 80 Pos > Neg Events/N 31/660 13/32 4/62 50/84 60 DFS Neg > Pos 6M-DFS 98.0% 62.5% 100% 58.3% 40 HR 0.8 9.2 Reference 15.8 Pos > Pos 95%CI 0.27–2.15 3.0–28.4 - 5
Slide 13: Key takeaways
Key takeaways Prognostic results Predictive results Circulate Japan ASCO GI 221 ● Signatera-positive post surgery: benefit significantly from adjuvant chemo (HR 8.8-9.4 12M-DFS for MRD-positives 55.5% in high-risk Stage II or III) 12M-DFS for MRD-negatives 95.2% ● Signatera-negative post surgery: no
Slide 14: Acknowledgements
Acknowledgements We would like to thank all the patients and their families for their participation as well as the study investigators and study teams for their contribution. Co-authors CIRCULATE-Japan Masahito Kotaka 1), Hiromichi Shirasu 2), Jun Watanabe 3), Kentaro Yamazaki 2), Keiji Hirata 4), R
Slide 15: Announcing expansion: pancreatic cancer
Announcing expansion: pancreatic cancer Stratification by ctDNA Overview • ~60K new cases per year, 40-45% early stage1, 85% recurrence after surgery • Unmet need: surveillance for early recurrence already recommended by guidelines2, but CA19-9 lacks sensitivity/specificity. 5-10% don’t express CA19
Slide 16: Announcing expansion: anal cancer
Announcing expansion: anal cancer Stratification by ctDNA Overview • 9K new cases per year1 • Unmet Need: No established biomarkers, imaging difficult to interpret after definitive treatment, invasive surveillance tools • 10-30% of patients recur loco-regionally. MRD+ patients post definitive treatm
Slide 17: Conclusions
Conclusions • Signatera is prognostic and predictive of treatment benefit in CRC; with exceptional sensitivity • Increases likelihood of adoption into guidelines and private payor coverage • Expands Natera’s data leadership in CRC and other GI cancers • Tumor-informed & personalized approach: great
Slide 18: Q&A
Q&A 18 Not for reproduction or further distribution.
Slide 19: Not for reproduction or further distribution. Natera, Inc. Inc.
©2020 Natera, Inc.Inc. All Rights Reserved. NotNot for reproduction or further distribution. 19 Not for reproduction or further distribution. ©2022 Natera, All Rights Reserved. for reproduction or further distribution.
Slide 20: 2 oral presentations, 4 posters
2 oral presentations, 4 posters Oral presentations Posters ORAL ABSTRACT SESSION C: Cancers of the POSTER SESSION C: Cancers of the Colon, Rectum, and Anus Presenter: Georges Azzi, M.D Colon, Rectum and Anus Circulating tumor DNA-based molecular residual disease detection and Presenter: Masahito Kot