Nuvation Bio's David Hung on Building a Pipeline of Best-in-Class Oncology Drugs
核心洞察
Nuvation Bio's Ibtrozi, a ROS1 (搜索) TKI for NSCLC, demonstrated a 90% response rate and 50-month duration of response, which CEO David Hung calls the highest combined rate ever seen for any drug in any cancer.
The company's brain tumor drug safusidenib showed a 44% response rate in low-grade glioma (搜索) and striking complete responses in high-grade glioma, including a glioblastoma patient tumor-free for over three years.
Nuvation Bio is well capitalized with over $535 million in cash and used a royalty financing strategy, selling 5% of Ibtrozi U.S. sales for $150 million to fund development.
Nuvation Bio is carving out a distinct position in the oncology landscape with a pipeline that its founder and CEO, Dr. David Hung, believes represents not just more drugs, but better ones. In recent interviews, Hung detailed the company's strategy of pursuing first-in-class and best-in-class assets, supported by disciplined dealmaking and innovative financing.
"We feel that patients don't need more drugs, they need better drugs," Hung told Pharmaceutical Executive. "When you have a lot of drugs that are very similar and spend a lot of marketing dollars trying to tout really nonexistent differences between them, that's not doing patients a service."
Ibtrozi: A Landmark in ROS1 (搜索)-Positive NSCLC
In June 2025, the FDA approved Ibtrozi (taletrectinib) (搜索), a next-generation oral ROS1 (搜索) tyrosine kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (搜索). The approval was supported by clinical data that Hung describes as unprecedented.
"Ibtrozi demonstrated a 90% response rate and 50 month duration of response, which is really the highest combined response rate and duration of response ever seen for any drug in any cancer," Hung said. The drug is now in its third quarter of commercial launch in the United States, and Nuvation is advancing it into earlier lines of therapy with an adjuvant study in ROS1 (搜索) patients — the only ROS1 TKI being developed in that setting.
The UK's drug regulatory body has also accepted the marketing application for taletrectinib, signaling international expansion. Nuvation has established partnerships for commercialization outside the U.S., including Innovent Biologics in China, Nippon Kayaku in Japan, and a recently announced deal with Eisai covering Europe and other regions.
Safusidenib: Targeting an Unmet Need in Glioma (搜索)
Nuvation's second late-stage asset, safusidenib, targets mutant IDH1 (搜索), a driver of multiple brain tumor types. The drug has generated compelling data across both low-grade and high-grade gliomas.
In low-grade glioma (搜索), safusidenib achieved a 44% response rate in early trials, with a progression-free rate at two years of 87.9% — meaning only about 12% of patients progressed. At the most recent five-year follow-up, nearly half of those patients remained on treatment.
Perhaps more striking are the responses in high-grade glioma (搜索), where no drug has previously demonstrated meaningful activity. "We have one patient with a glioblastoma multiforme (搜索), the worst of the worst brain tumors," Hung said. "That patient has now had a complete response, which means a tumor has been gone for about three and a half years so far, and another patient with another high-grade glioma, whose tumor has now disappeared for about two years."
The company is running multiple pivotal studies for safusidenib, targeting all four segments of the glioma (搜索) opportunity: high-grade and low-grade, each subdivided into high-risk and low-risk categories.
A Novel Drug-Drug Conjugate Platform
Beyond its late-stage assets, Nuvation is advancing a drug-drug conjugate (DDC) platform designed to address limitations of antibody-drug conjugates. Hung explained that ADCs, while effective, rely on large antibody molecules that often cannot traverse cell membranes efficiently, sometimes requiring premature payload release that causes peripheral toxicity.
"We've developed the DDC program, where we fuse two small molecules together," Hung said. "These can be warheads, targeting agents, or a combination of any or all of them. And we've shown that these are many, many times smaller than an ADC." The first DDC program is expected to be announced later this year.
Financial Discipline and Strategic Deal making
Nuvation Bio's financial position is notably strong for a biotech of its size, with over $535 million in cash. The company's first quarter revenue exceeded analyst expectations by nearly 26%.
Hung attributes this stability to a multi-pronged financing approach. The acquisition of AnHeart Therapeutics (搜索) — which brought both Ibtrozi and safusidenib into Nuvation's pipeline — was structured as an all-stock transaction giving AnHeart shareholders 33% of the combined company. "Now, two years later … we have a market cap of over $2 billion. So, it ended up being a good financial deal," Hung told PharmaVoice.
To fund the launch of Ibtrozi and development of safusidenib, Nuvation employed royalty financing, selling 5% of Ibtrozi U.S. sales — valued at $3 billion — to secure $150 million, along with an additional $100 million loan.
"The name of the game is to No. 1, not die, and two, to get to where you want to go," Hung said. "And to get where you want to go, you have to have a cash runway of some sort."
A Track Record of Oncology Success
Hung's approach is informed by his experience as founder of Medivation (搜索), where he developed Xtandi, now a global blockbuster in prostate cancer. That company was acquired by Pfizer in a headline-generating $14 billion deal. A second Medivation drug, Talzenna, approved for breast cancer, recently showed strong phase 3 results combined with Xtandi in prostate cancer, boosting progression-free survival by 50% compared with placebo.
"We won't work on anything that we don't think is either first-in-class or best-in-class," Hung said. "We're extremely objective about data. I'm passionate about my business, but very dispassionate about my data. We just try not to drink our own Kool-Aid."