BioNTech’s Pumitamig Challenges Standard of Care as ASCO Data and Analyst Upgrade Bolster Oncology Pivot

BioNTech’s most ambitious oncology candidate, pumitamig, is being positioned as a direct competitor to Merck’s blockbuster Keytruda, and the latest clinical results from the ASCO congress suggest the challenger has real heft. The bispecific antibody — which targets both PD-L1 and VEGF-A — delivered striking response rates in first-line non-small cell lung cancer (NSCLC), while a simultaneous UBS upgrade and a deep corporate restructuring signal that the German biotech is serious about transforming its post-Covid future.

The data, drawn from the ROSETTA Lung-02 study and presented on May 30, cover 40 evaluable patients with previously untreated advanced NSCLC. At a median follow-up of 9.0 months, the confirmed objective response rate hit 57.1% in non-squamous disease and climbed to 68.4% in the squamous variant. More striking still, the disease control rate across all patients stood at 100% — every single tumour shrank or stabilised. The responses held even at low PD-L1 expression levels: among patients with a tumour proportion score below 1%, the response rate was 47.6%, while it reached 77.8% in the intermediate group and 100% in those with TPS of 50% or higher.

Safety data, meanwhile, showed a manageable profile. Grade 3 or higher adverse events occurred in 48.8% of patients, with 23.3% deemed related to pumitamig. The discontinuation rate due to side effects was 9.3%, a level BioNTech and its partner Bristol Myers Squibb consider acceptable. Based on the interim analysis, the companies have selected a dose of 1,500 mg every three weeks for the pivotal Phase 3 portion, which is already enrolling patients. That arm will directly compare pumitamig plus chemotherapy against the current standard of pembrolizumab plus chemotherapy.

Beyond ROSETTA Lung-02, BioNTech is running a total of seven global Phase 3 studies of pumitamig across lung, breast, colorectal and gastric cancers, with more than 2,000 patients treated to date. In the lung segment alone, two additional late-stage trials are under way: ROSETTA Lung-201 tests pumitamig against durvalumab after chemoradiotherapy in stage III disease, and ROSETTA Lung-202 compares it head-to-head with pembrolizumab in first-line PD-L1-high NSCLC. The scope of the programme makes clear that BioNTech’s strategy is not to carve out a niche, but to take on the established order across multiple tumour types and disease stages.

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The push comes as the company’s financial position remains formidable. As of March 31, 2026, BioNTech held €16.8 billion in cash, cash equivalents and securities, and its board has authorised a share buyback of up to $1 billion over the next twelve months. At the same time, the group is executing a cost-cutting drive that will see it leave production sites in Idar-Oberstein, Marburg, Singapore and former CureVac locations, affecting up to 1,860 roles. The savings are expected to reach around €500 million annually by 2029, freeing up capital to fund the oncology pipeline.

That pipeline’s breadth was on full display at ASCO. Alongside pumitamig, BioNTech presented Phase 2 data from the PRESERVE-004 study of gotistobart plus pembrolizumab in heavily pre-treated, platinum-resistant ovarian cancer, reporting durable antitumour activity and clinically relevant survival. Additional presentations covered antibody-drug conjugates targeting HER3, B7H3 and HER2. Overall, the oncology pipeline now encompasses more than 25 clinical trials in mid- and late-stage development, with 13 programmes considered registration-enabling.

UBS has taken notice. Analyst David Dai upgraded BioNTech from Neutral to Buy and lifted the price target from $117 to $135. In a note, Dai called pumitamig a credible candidate for a leading position in its drug class. The bank projects BioNTech revenue of €2.10 billion in 2026, rising to €4.44 billion by 2030, with a net profit of €398 million expected that same year — a return to profitability that hinges squarely on clinical and commercial success in oncology.

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The stock’s reaction, however, has been muted. BioNTech shares currently trade at €78.80, down 4.31% on the day and off 20.32% over the past twelve months. The market has yet to fully price in the clinical momentum, in part because the competition is intensifying. Summit Therapeutics and Akeso have already presented data on ivonescimab in China, and the US Phase 3 Harmoni-3 study is expected to deliver results later this year.

For BioNTech, the real inflection point will not come from a single ASCO presentation. The upcoming data readouts from ROSETTA Lung-02’s pivotal segment and the two other Phase 3 lung studies will determine whether pumitamig can convert early promise into a durable threat to Keytruda’s dominance. With a deep balance sheet and a clear-eyed cost plan, the company has bought itself the time and resources to find out.

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BioNTech Stock: New Analysis - 2 June

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