Dive Brief:
- A targeted radiation drug being developed by Indianapolis-based Point BioPharma met its goal in a late-stage prostate cancer study, but fell short of analyst expectations for a greater treatment benefit.
- Point’s drug, a type of therapy known as a radiopharmaceutical, kept study participants’ prostate cancer at bay for a median of 9.5 months, compared to six months for those given a standard hormonal treatment. The 29% reduction in relative risk was statistically significant, Point and partner Lantheus Holdings said Monday.
- However, analysts had forecast a higher median profession-free survival of between 10 to 12 months, expectations that likely factored into Point shares falling by double digits during Monday morning trading. Dubbed PNT2002, Point’s drug is similar to an approved therapy from Novartis called Pluvicto, which was recently tested in a similar prostate cancer setting.
Dive Insight:
Point’s study data, while missing analyst expectations, may hasten the company’s pending takeover by Eli Lilly, which in early October agreed to pay $1.4 billion to acquire the radiopharma drugmaker.
Lilly has been forced several times to delay the deadline for Point investors to tender their shares to the deal, which requires a majority of stockholders to agree to sell. Lilly has only managed to secure the support of about one-quarter of Point shares at deadlines of Nov. 16, Dec. 1 and last Friday.
The main reason, analysts suspect, is that investors have been waiting for Point’s prostate cancer study, called SPLASH, to read out results. Were results to show Point’s drug superior to Novartis’ Pluvicto, the thinking went, investors could demand a higher price from Lilly or, potentially, another buyer. At least one Point shareholder indicated as much.
That hasn’t panned out, as Point’s results “meaningfully disappointed,” according to Faisal Khurshid, an analyst at Leerink Partners.
Several stockholders have resisted selling their shares “on the belief that SPLASH would show comparability of PNT2002 to Pluvicto and that this could potentially support a higher deal price,” Khurshid wrote in a note to clients. “Given today's data we believe these hopes are likely to wash away.”
Lilly has now extended its deadline to 5:00 pm Eastern time on Dec. 22 for Point shareholders to tender their stock. The company’s offer of $12.50 per share represented an 87% premium to Point shares’ price the day prior to the deal’s announcement. In the run-up to the SPLASH results, shares rose above $14 per share, but fell back Monday to $12.46 apiece.
PNT2002, like Pluvicto, is designed to deliver a targeted dose of radiation directly to tumors by linking a lutetium isotope to a targeting compound that homes in on a protein called PSMA. This protein is found on the surface of prostate cancer cells, making it a natural drug target.
In SPLASH, Point enrolled 412 people with PSMA-expressing metastatic prostate cancer that was resistant to castration. Participants had previously received hormonal therapy and either couldn’t receive or refused subsequent chemotherapy treatment. They were randomized 2:1 to receive Point’s drug or either Zytiga or Xtandi.
Importantly, participants in the control arm could “cross over” to receive PNT2002 if their disease progressed. Some 84% of those who experienced progression ended up doing so, potentially confounding the study’s survival results. At the time of the analysis, survival results favored the control arm, but the picture could change as more data are accrued as the study continues. Point said additional results are expected next year, after which it may seek approval from the Food and Drug Administration.
A similar pattern happened in Novartis’ study of Pluvicto, which showed treatment led to a median progression-free survival of 12 months, but no survival benefit. The Swiss drugmaker has delayed plans to seek FDA approval until it has more survival data in hand.
For Lilly, the SPLASH results may be beside the point. Executives had downplayed the potential for SPLASH to prove PNT2002 superior to Pluvicto, and indicated their interest in Point had equally as much to do with the company’s manufacturing and research capabilities.
“Our interest in Point is a lot around the platform,” said Lilly’s Chief Scientific and Medical Officer Dan Skovronsky at an investor conference in late November. “I think the time is right to get into therapeutic radiopharmaceuticals.”