Pfizer PFE announced positive results from the phase III CREST study that evaluated its investigational PD-1 inhibitor sasanlimab in patients with BCG-naïve, high-risk, non-muscle invasive bladder cancer (NMIBC), including patients with carcinoma in-situ (CIS).

Results from the study showed that treatment with subcutaneously administered sasanlimab combined with standard-of-care BCG vaccine resulted in a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) compared to BCG alone.

PFE Boasts CREST Study Results as Game Changer

Though Pfizer did not share any numbers supporting this data, management mentioned that the study results mark a significant milestone in a therapeutic area that has seen little progress over the past 30 years. It also mentioned that the drug’s safety profile was consistent with other PD-1 inhibitors.

If approved, Pfizer claims that sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong EFS in the BCG-naïve high-risk NMIBC patient population.

Per management, nearly 100,000 people across the globe are diagnosed with high-risk NMIBC annually. While the BCG vaccine has been the long-standing standard of care, 40-50% of patients face disease recurrence and often require high-risk radical cystectomy due to limited treatment options.

The latest study results also give the company an edge over Merck’s MRK blockbuster PD-1 inhibitor Keytruda, which is also approved in the high-risk NMIBC indication. However, the approval of Merck’s drug is limited to patients unresponsive to BCG.

Although primarily used to prevent tuberculosis, the BCG vaccine is also a standard treatment for some forms of bladder cancer.

PFE Stock Performance

In the past year, shares of Pfizer have lost nearly 7% compared with the industry’s 2.5% fall.

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PFE’s Future Plans for Sasanlimab

Management intends to discuss the CREST study results with the FDA and other regulatory authorities to support potential filings for the sasanlimab-BCG combo in the NMIBC indication. It also plans to present detailed results from the CREST study at a future medical meeting.

Apart from the CREST study, Pfizer is evaluating the drug in combination with its antibody-drug conjugate portfolio in advanced solid tumors.

PFE’s Zacks Rank

Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Pfizer Inc. Price

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Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Castle Biosciences CSTL and Erasca ERAS, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Bottom-line estimates for Castle Biosciences have improved from a loss of 8 cents per share to earnings of 34 cents for 2024 in the past 60 days. During the same timeframe, loss per share estimates for 2025 have narrowed from $1.88 to $1.84. In the past year, shares of Castle Biosciences have surged 51%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for Erasca’s 2024 loss per share have improved from 90 cents to 73 cents. Estimates for 2025 loss per share have narrowed from 82 cents to 61 cents during the same timeframe. In the past year, Erasca’s shares have risen nearly 23%.

ERAS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 7.04%.

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