Why did the new prostate cancer drug’s data attract attention?

  • Johnson & Johnson presented phase I results for JNJ-6143 at the European Society for Medical Oncology annual meeting. Goldman Sachs said discussions at the meeting indicated that the previously little-followed data had delivered an unexpectedly positive surprise.
  • Among patients receiving the 50 mg dose selected for phase II whose tumors were evaluable by imaging, 12 of 16 achieved a complete or partial response, for a response rate of 75% and a median response duration of 11 months. Enrolled patients had received a median of 4 prior therapies, which Goldman Sachs believes makes the results more striking.
  • Among the relevant evaluable patients, 24 of 31 had a confirmed decline of at least 50% in prostate-specific antigen (PSA) levels, and 15 had a decline of at least 90%. The report said all adverse events were low grade and there were no serious treatment-related adverse events; however, this remains an early study with a small sample.

What could the new mechanism change, and how are subsequent trials progressing?

  • JNJ-6143 comes from the RIPTAC platform Johnson & Johnson acquired through its purchase of Halda. As Johnson & Johnson previously explained, the platform acts on both cancer-promoting proteins and proteins that help cells survive, with the aim of addressing drug resistance.
  • Experts in post-meeting discussions said the mechanism could still exploit androgen receptor (AR) expression even when AR signaling is no longer the main driver of the cancer; this is also a potentially novel feature. The experts also noted that some patients’ responses lasted more than 8 months, and patients with unfavorable genetic alterations also experienced deep PSA declines and tumor responses.
  • An open-label, single-arm phase II trial of 50 mg oral monotherapy once daily has started, and a phase I dose-escalation trial of combination treatment is also under way. The report quoted investigators as saying the balance of safety and efficacy supports starting a randomized phase III trial.

What progress did the other head and neck cancer data show?

  • The phase Ib/II cohort of OrigAMI-4 tested subcutaneous Rybrevant combined with Keytruda and chemotherapy as first-line treatment for head and neck squamous cell carcinoma. Goldman Sachs said the data met its threshold for expectations.
  • Among patients with non-HPV-related disease, the confirmed overall response rate was 77%, including a complete response rate of 14%; tumors shrank in all evaluable patients, and 65% of responses were ongoing at a median follow-up of 10.6 months.
  • The report said the combination’s safety was manageable and consistent with the known profiles of its component drugs; the results support the ongoing pivotal phase III OrigAMI-5 trial.

How does Goldman Sachs view Johnson & Johnson’s commercial opportunity and valuation?

  • Goldman Sachs believes JNJ-6143 could create a new product cycle on the foundation of Johnson & Johnson’s existing prostate cancer business, which includes Zytiga, Erleada and Akeega, and has the potential to become a multibillion-dollar blockbuster; the firm has not yet specifically included this opportunity in its model.
  • Goldman Sachs rates Johnson & Johnson Buy and has a 12-month price target of 280 dollars, calculated at 19.5 times its forecast earnings per share for the 5 through 8 upcoming quarters. Downside factors cited in the report include a slower-than-expected ramp-up of new products, higher-than-expected talc litigation payouts, and pressure from the macroeconomic environment and tariffs.