Sasanlimab

Pfizer Europe MA EEIG withdrew its EU marketing authorization application for Zumrad (sasanlimab), a subcutaneous PD-1–blocking monoclonal antibody being developed with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC), according to an EMA questions and answers document. The EMA said Pfizer withdrew the application on February 13, 2026, after the agency had evaluated the initial dossier and was assessing the company’s responses to CHMP questions. In its provisional view at the time of withdrawal, the EMA said Zumrad could not have been authorized based on the available data. The agency cited concerns that major changes were made while the pivotal study was ongoing, and that the statistical method used to determine efficacy was also changed, which the EMA said increased the chance of concluding benefit. The EMA also questioned whether the primary effectiveness measure—assessed by investigators in a setting where “researchers and participants knew which treatment was being given”—was appropriate, and said it was unclear whether the effect size represented a meaningful patient benefit. The agency added that outcomes such as overall survival did not support the primary endpoint finding, and that adding sasanlimab to BCG resulted in more side effects, including immune-related events, plus more BCG interruptions and discontinuations. Pfizer told the EMA it withdrew the application to allow for additional data collection and analyses to address the agency’s questions and concerns, and said there were no consequences for patients in ongoing clinical trials using Zumrad. The application was supported by a main study in 1,055 adults with high-risk NMIBC who were BCG-naïve or had not received BCG within the prior two years. In the study, Zumrad plus BCG was compared with BCG alone. Sasanlimab was administered once every four weeks for up to two years, while BCG was given weekly for six weeks followed by maintenance across five cycles, the EMA said. The primary measure was time free of events including recurrence or worsening, presence of cancer cells in the bladder lining, or death from any cause; overall survival was also evaluated. Pfizer has previously publicly disclosed positive Phase III results for sasanlimab plus BCG in high-risk NMIBC (the CREST program), including publication of CREST data in Nature Medicine, but the EMA document indicates the agency’s review focused on whether the evidence package was sufficient for authorization as filed. From a treatment-landscape perspective, NMIBC drug development has accelerated in BCG-unresponsive disease, where the US FDA has approved multiple non-surgical options, including pembrolizumab (Keytruda) for BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS) (2020), nadofaragene firadenovec (Adstiladrin) gene therapy (2022), and nogapendekin alfa inbakicept-pmln (Anktiva) with BCG (2024). Mechanistically, Zumrad targets the PD-1 checkpoint on T cells, aiming to prevent tumor-driven immune suppression via PD-L1/PD-L2 binding and thereby enhance anti-tumor immune activity—an approach that has reshaped systemic oncology but has faced design and endpoint challenges in earlier-stage, bladder-sparing NMIBC trials where recurrence-based measures, investigator assessment, and intravesical therapy schedules can meaningfully influence interpretability.

“TARA-002 overcomes the limitations of existing NMIBC treatments that burden patients as well as urologists and their practices,” Protara Therapeutics\' CEO said.\n Protara Therapeutics has touted a 66% complete response (CR) rate for its cell therapy among certain bladder cancer patients as “impressive,” despite this rate halving at the 12-month mark.The New York-based biotech has been evaluating TARA-002—a cell therapy designed to activate immune cells within the tumor and generate a pro-inflammatory response—in the phase 2 open-label Advanced-2 trial of patients with high-risk non-muscle invasive bladder cancer (NMIBC). The participants either haven’t received or were unresponsive to Bacillus Calmette-Guérin (BCG), an immunotherapy used as the standard of care in the indication.Among BCG-unresponsive patients, the latest interim analysis showed that 15 out of 22 (68.2%) of evaluable patients had experienced CR as of Jan. 28. However, this rate had dropped to five of 15 patients (33.3%) among patients who had reached 12 months of treatment.Raj Satkunasivam, M.D., the study’s investigator, described the 12-month data as “maturing” while showing “promising signals of durability,” in the company\'s Feb. 24 release.“These clinically meaningful response rates and favorable tolerability profile make TARA-002 a potentially promising treatment option,” added Satkunasivam, who is a urologic oncologist and associate professor at Houston Methodist Hospital.The data were more consistent among the BCG-naïve cohort, where the CR was 66.7% (18 out of 27 patients) at six months and 57.9% (11 of 19) at 12 months. Protara will share the data at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco on Friday.When it came to tolerability, the majority of treatment-related adverse events (TRAEs) were grade 1 and transient, Protara noted. There with no TRAEs graded 3 or above, and no patients discontinued treatment due to TRAEs, the company added. But investors appeared unsure about the latest readout, sending Protara’s stock down 12% in premarket trading Tuesday to $6.50 from a Monday closing price of $7.43.This morning’s market reaction was a far cry from December 2024, when the biotech saw its share price double on the back of earlier data from the same study that suggested a 72% six-month CR across BCG exposures. This included an 100% CR rate at six months among four evaluable BCG-unresponsive patients, who Protara said at the time are designed to be a registrational cohort and align with FDA draft guidance for the specific patient population.Still, Protara CEO Jesse Shefferman said the data generated from the trial to date “highlight TARA-002’s potential as a meaningful addition to the treatment landscape.” “In addition to demonstrating impressive efficacy and safety, TARA-002 overcomes the limitations of existing NMIBC treatments that burden patients as well as urologists and their practices,” Shefferman added.“We look forward to continuing to advance TARA-002’s clinical development as we work to bring this treatment to patients,” the CEO added.The company has now reached its target enrollment of 31 patients who haven’t received BCG therapy and is continuing to enroll patients who were unresponsive to that treatment. The biotech said it remains on track to launch another study specifically in BCG-naïve patients in the second half of the year.NMIBC makes up about 80% of bladder cancer cases, with about 65,000 Americans diagnosed with the form of bladder cancer every year. Merck & Co.’s blockbuster PD-1 inhibitor Keytruda is already approved to treat patients with BCG-unresponsive NMIBC, while Pfizer and AstraZeneca are hoping their own PD-1 drugs sasanlimab and Imfinzi, respectively, will also gain the FDA nod.