From 47.6% to 100%: BioNTech's Pumitamig Shows Broad Activity Across PD-L1 Subtypes at ASCO

Even lung cancer patients with no PD-L1 expression saw a confirmed objective response rate of 47.6% on BioNTech's pumitamig combination therapy, according to interim data unveiled at the American Society of Clinical Oncology annual meeting. At the other end of the spectrum, those with high PD-L1 levels (TPS ?50%) registered a complete response. The disease control rate across all 40 evaluable patients hit 100%, a figure that underscores the breadth of the bispecific antibody's mechanism.

The data carry an unusual twist: the lower dose of 1,400 mg outperformed the standard dose. In that cohort, the confirmed overall response rate reached 72.7% for squamous non-small cell lung cancer and 63.6% for non-squamous disease, compared with 68.4% and 57.1% across the full dataset. That inverse dose-response has caught the attention of oncologists, hinting at a wider therapeutic window than initially assumed.

BioNTech and partner Bristol Myers Squibb presented results from the ROSETTA Lung-02 phase 2 study, which is testing pumitamig plus chemotherapy in previously untreated advanced NSCLC. The data cutoff was April 13, 2026, with a median follow-up of 9.0 months. Pumitamig, a bispecific immunomodulator that simultaneously blocks PD-L1 and VEGF-A, aims to combine checkpoint inhibition with anti-angiogenesis in a single molecule.

The safety profile landed within expected ranges for this class. Treatment-related adverse events of grade 3 or higher occurred in 48.8% of patients, with 23.3% considered pumitamig-related. Four patients, or 9.3%, discontinued therapy due to side effects. Immune-mediated events affected 37.2% of the group, though severe immune-mediated events were limited to 4.7%.

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Regulatory momentum is already building. Following discussions with the US Food and Drug Administration, the partners have set progression-free survival as the primary endpoint for the ongoing phase 3 portion of ROSETTA Lung-02, with overall survival as a key secondary measure. That study has been expanded to roughly 1,260 patients to ensure statistical power, and pits pumitamig plus chemo directly against pembrolizumab plus chemo. Two additional trials are also enrolling: ROSETTA Lung-201 for stage III disease after concurrent chemoradiotherapy, and ROSETTA Lung-202 for first-line advanced PD-L1-high NSCLC.

On the XETRA exchange, BioNTech shares closed Friday at €82.35, up 2.68% on the day. The stock sits 1.59% above its 50-day moving average but remains 4.45% below the 200-day line. On a 12-month view, the equity is essentially flat and roughly 19% off the 52-week high of €101.90.

The biotech's financial firepower remains considerable. Cash and securities totalled €16.76 billion at the end of the first quarter, with €9.94 billion in liquid assets and €4.70 billion in short-term investments. That war chest is funding 15 planned phase 3 studies, even as the company burns through cash in its transformation. First-quarter revenue came in at €118.1 million, generating an operating loss of €494.6 million and a net loss of €531.9 million, or €2.10 per diluted share. Management reiterated full-year 2026 revenue guidance of €2.0 billion to €2.3 billion.

BioNTech at a turning point? This analysis reveals what investors need to know now.

UBS upgraded the stock to Buy on May 27, lifting its price target to $135 from $117 and citing pipeline strength. The ASCO readout offers the strongest clinical validation yet that BioNTech's pivot from COVID vaccine maker to oncology powerhouse is on track. But the true verdict will come from the randomised phase 3 data, where pumitamig must prove it can beat established standards in a much larger patient population.

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