Arvinas, Inc. · NASDAQ:ARVN
Arvinas — ASCO Genitourinary Cancers Symposium 2022
23 slides from Arvinas's conference presentation, Feb 17, 2022
Slide 1: Bavdegalutamide (ARV-110): Phase 1 Dose Escalation and Interim ARDENT Phase 2 Results
Bavdegalutamide (ARV-110): Phase 1 Dose Escalation and Interim ARDENT Phase 2 Dose Expansion Trial Results February 17, 2022 ASCO Genitourinary Cancers Symposium, 2022 Exhibit 99.2
Slide 2: Forward-looking statements
This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential advantages and therapeutic benefits of bavdegalutamide (ARV-110), the develo
Slide 3: Phase 1 completed; ARDENT enrolled; signals support potential accelerated approval
The Phase 1 trial for bavdegalutamide (ARV-110) has completed and nearly all patients in the Phase 2 ARDENT trial have enrolled Data to date demonstrated AR T878X/H875Y mutations correlated with high tumor responsiveness to bavdegalutamide 46% PSA50 in all patients with AR T878X/H875Y tumor mutation
Slide 4: Migration of novel hormonal agents to earlier settings has created unmet need in mCRPC
Novel therapies for 2L/3L patients Post-NHA treatment in earlier-line settings Key Unmet Needs: Migration of novel hormonal agents to earlier settings has created substantial unmet need for new treatments in mCRPC Castration Sensitive (~200k) US Prostate Cancer Treatment Paradigm (# of US patients†)
Slide 5: Previously released interim Phase 1 data suggested a promising efficacy profile
Interim results from the Phase 1 dose escalation trial (n=37; presented December 2020)* Heavily pretreated patient population, with a median of 5 prior lines of therapy 76% of patients received prior chemotherapy 82% received both abiraterone and enzalutamide 84% had non-AR gene mutations Two of fiv
Slide 6: The ARDENT Phase 2 trial was designed to answer key questions
The ARDENT Phase 2 trial was designed to answer 3 key questions The ARDENT trial was designed to answer 3 key questions: Are the safety and tolerability of bavdegalutamide acceptable for use in a post-NHA mCRPC patient population? Is efficacy signal sufficiently robust (>25% PSA50) in tumors with AR
Slide 7: Phase 1 and Phase 2 trials enrolled post-NHA patient populations
Parameter Phase 1 (n=71) Phase 2* (n=124) Median age (range), yrs 70 (51–85) 74 (48–91) ECOG performance status,† n (%) 0 46 (65) 61 (49) 1 25 (35) 62 (50) Visceral disease,‡ n (%) 31 (44) 38 (31) Median no. lines of prior therapy (range) 6 (2–14) 4 (1–11) Type of prior therapy, n (%) Novel hormonal
Slide 8: The ARDENT Phase 2 trial was designed to answer key questions
The ARDENT Phase 2 trial was designed to answer 3 key questions Are the safety and tolerability of bavdegalutamide acceptable for use in a post-NHA mCRPC patient population? Is efficacy signal sufficiently robust (>25% PSA50) in tumors with AR T878X/H875Y mutations to support potential for accelerat
Slide 9: Manageable tolerability profile at the RP2D (420 mg, oral, once daily)
Bavdegalutamide had a manageable tolerability profile at the RP2D (420 mg, oral, once daily) Low dose reduction and discontinuation rates due to TRAEs Dose reduction rate: 8% Discontinuation rate: 9% No grade ≥4 TRAEs at the RP2D *Includes 14 phase 1 patients (9 treated at 420 mg QD and 5 treated at
Slide 10: The ARDENT Phase 2 trial was designed to answer key questions
The ARDENT Phase 2 trial was designed to answer 3 key questions AR=androgen receptor; mCRPC=metastatic castration resistant prostate cancer; NHA=novel hormonal agent; T878X=T878A or T878S Are the safety and tolerability of bavdegalutamide acceptable for use in a post-NHA mCRPC patient population? Is
Slide 11: PSA reductions seen across all subgroups, most notably in T878X/H875Y mutant tumors
L702H/AR-V7† (n=25)* PSA50=4% T878X/H875Y (n=8)* PSA50=75% PSA reductions were seen across all subgroups in the ARDENT trial, most notably in patients with AR T878X/H875Y mutant tumors WT/Other (n=44)* PSA50=11% Less Pretreated‡ (n=27)* PSA50=22% Phase 2 patients only *Includes biomarker-evaluable p
Slide 12: 46% PSA50 in patients with AR T878X/H875Y tumor mutations
46% PSA50 in all patients with AR T878X/H875Y tumor mutations in Ph 1 and across all ARDENT subgroups supports the potential for accelerated approval Best % PSA Change From Baseline PSA50 PSA30 AR T878X/H875Y (n=28)* PSA50=46% PSA30=57% *Includes biomarker-evaluable patients treated at or above the
Slide 13: Robust duration of treatment in patients with mutant tumors
Bavdegalutamide showed robust duration of treatment in Phase 1 and ARDENT trial patients with AR T878X/H875Y mutant tumors Time on Treatment, Weeks AR T878X/H875Y (n=28*) Continuing on treatment 12 (43%) patients received bavdegalutamide for ≥24 weeks 9 patients remaining on treatment at data cutoff
Slide 14: Durable partial responses in RECIST-evaluable patients with mutant tumors
Durable partial responses in 2 of 7 RECIST-evaluable patients with AR T878X/H875Y mutant tumors Best % Target Lesion Diameter Change From Baseline PD PD SD SD SD PR PR AR T878X/H875Y (RECIST evaluable, n=7)*,† Continuing on treatment *Includes biomarker-evaluable patients treated at or above the rec
Slide 15: Data support a potential path to accelerated approval in molecularly defined mCRPC
Data support a potential path to accelerated approval in molecularly defined mCRPC Phase 2 enrollment ongoing (December 20, 2021 data cutoff date) AR=androgen receptor; mCRPC=metastatic castration resistant prostate cancer; NHA=novel hormonal agent; PSA50=best PSA declines ≥50%; T878X=T878A or T878S
Slide 16: Potential opportunity for bavdegalutamide as a precision medicine in prostate cancer
Potential opportunity for bavdegalutamide as a precision medicine for patients with prostate cancer * Ledet et al., The Oncologist 2019;24 AR=androgen receptor; mCRPC=metastatic castration resistant prostate cancer; CSPC-castration sensitive prostate cancer; NHA=novel hormonal agent; ctDNA=circulati
Slide 17: The ARDENT Phase 2 trial was designed to answer key questions
The ARDENT Phase 2 trial was designed to answer 3 key questions AR=androgen receptor; mCRPC=metastatic castration resistant prostate cancer; NHA=novel hormonal agent; T878X=T878A or T878S Are the safety and tolerability of bavdegalutamide acceptable for use in a post-NHA mCRPC patient population? Is
Slide 18: Rationale for the less-pretreated subgroup
Rates of genetic mutations are known to increase over time and with multiple treatments, leading to the potential for high AR-independence The ARDENT trial is evaluating the efficacy of bavdegalutamide in a subgroup of “less pretreated” patients*, hypothesizing that this population would have fewer
Slide 19: Molecular profiles similar between less and more pretreated subgroups
Molecular profiles were similar between patients in the “less pretreated” and “more pretreated” subgroups of ARDENT *Includes biomarker-evaluable patients (those with circulating tumor DNA or tumor samples evaluable by DNA sequencing and, where applicable, blood samples evaluable for AR-V7) treated
Slide 20: PSA response rates similar between less and more pretreated subgroups
PSA response rates were similar between the “less pretreated” and “more pretreated” subgroups in ARDENT *Includes biomarker-evaluable patients (those with circulating tumor DNA or tumor samples evaluable by DNA sequencing and, where applicable, blood samples evaluable for AR-V7) treated at or above
Slide 21: Anticipated milestones in 2022
1H 2022: Discuss the potential accelerated approval path with the FDA Finalize partnership for companion diagnostic 2H 2022 Initiate pivotal trial for patients with AR T878/H875 tumor mutations Profile of bavdegalutamide potentially supports clear precision medicine opportunity in mCRPC AR=androgen
Slide 22: Conclusion
Robust signals of clinical activity in heavily pretreated patients with mCRPC who received 1–2 prior novel hormonal agents; supports potential path to accelerated approval In patients with AR T878X/H875Y mutant tumors: 46% PSA50 rate 2 of 7 RECIST-evaluable patients with durable partial responses; 6
Slide 23: Appendix
Appendix