Oncology competitive updates from Seagen & Astellas Q3'23 Earnings call

On November 1, 2023, Seagen reported Q3 2023 earnings (press release; no investor call held due to pending acquisition by Pfizer) and Astellas held their Q3 2023 (JPY Q2 2023) earnings call (presentation, webcast). 

Key Oncology Highlights

• Seagen and Astellas highlighted the strong growth of Padcev (enfortumab vedotin/EV), driven by increasing use in 1L cisplatin-ineligible mUC following FDA accelerated approval in Apr 2023
• Companies updated on timing of planned global regulatory submissions for EV (in combination with pembrolizumab) in 1L all-comer mUC based on the positive confirmatory P3 EV-302 trial results:
  • Anticipated US sBLA filing Q4’23; Astellas expects US approval by end of Q1’24
  • Expected global filing in Q1’24; estimates EU approval Q4’24
• Strength of EV-302 data presented at ESMO was emphasized, with Seagen highlighting its potential to be “practice changing and offer a new standard of care for first-line metastatic bladder cancer”
• The proposed acquisition of Seagen by Pfizer is still expected to close in late 2023/early 2024

Financials

• Seagen reported Q3 and 9-month 2023 revenues of USD $649M (+27% YoY) and $1.77B (+24% YoY), respectively
• Enfortumab vedotin Q3 and 9-month 2023 net product sales were $200M (+89% YoY; +24% QoQ) and $479M (+46% YoY), respectively – Q3 2023 net product sales beat FactSet consensus of $167.6M
  • Growth attributed to strong launch and uptake of EV + Pembro in 1L cis-ineligible mUC following Apr 2023 FDA accelerated approval
    • Astellas again reported that penetration of 1L cis-ineligible mUC indication in the US “continues to exceed expectations” and expects “further sales acceleration” in the future
  • Astellas noted reimbursement started in Germany and Italy; expected to support growth from Q4’23+

Bladder development updates

• P3 EV-302 (NCT04223856): Enfortumab vedotin (EV/Padcev; Nectin-4 ADC) + pembrolizumab (P/Keytruda; anti-PD-1) in 1L cis-eligible & cis-ineligible la/mUC
  • Companies emphasized P3 EV-302 results presented at ESMO (#LBA6) as having the “potential to be practice changing and offer a new standard of care for [1L mUC]” (Seagen) and as being “high value,” filling an extremely high unmet medical need (Astellas)
    • Pfizer also commented on the data during their earnings call (Oct 31, 2023), suggesting belief that final survival data will be “above/longer than 31.5 months”
  • Companies confirmed timing of planned full US and global regulatory filings for EV in combination with pembrolizumab in 1L mUC based on the EV-302 data:
    • Planned US sBLA filing in Q4 2023 and expectation of full US approval by end of Q1 2024 (per Astellas)
      • Astellas pulled up US filing timeline from prior guidance of Q1 2024 based on strength of EV-302 results
      • In the Q&A, Astellas responded to a question on the speed of US filing to approval by describing Padcev as being their “most prioritized product” and that they are seeking US approval “as early as possible”
    • Astellas guided global filing in Q1 2024; estimates EU approval Q4 2024
  • Enrollment of the extension study in China is also still ongoing
• P3 EV-303/KEYNOTE-905 (NCT03924895) and P3 EV-304/KEYNOTE-B15 (NCT04700124): perioperative EV + pembro in cis-ineligible or cis-eligible MIBC, respectively
  • Astellas continues to guide global regulatory filings of EV in MIBC in JP FY2025+ (Q2’25-Q1’26+)
• P3 SGNDV-001 / KEYNOTE-D74 (NCT05911295):disitamab vedotin (HER2 ADC) + pembro (PD-1) vs gemcitabine + cisplatin OR carboplatin in 1L HER2-expressing (IHC 1+ and greater) la/mUC
  • Seagen reiterated initiation of the P3 trial in Q3’23 but provided no additional update
  • No updates of the ongoing P2 RC48G001/KN-D78 NCT04879329) trial of DV +/- pembro in 1L HER2-expressing mUC (Cohort C) or DV mono in 2L+ HER2+ (Cohort A) or HER2-low (Cohort B) mUC 

NSCLC development updates

• P3 trial expected: SGN-B6A (integrin beta-6 targeting ADC)
  • Management reiterated plans to initiate a P3 trial of SGN-B6A vs docetaxel SoC in previously treated mNSCLC in Q4’2023
  • Note: SGN-B6A is currently under evaluation in the P1 basket study (NCT04389632) for solid tumors (including NSCLC)