Nektar Shares Halve on Cancer Trial Failure
Biotech Nektar Therapeutics and its partner Bristol Myers Squibb said early Monday that their cancer drug known as bempeg had failed in a trial in melanoma patients.
Shares of Nektar (ticker: NKTR) fell 61% in trading to $4.16 from its Friday close of $10.63. Shares of Bristol Myers (BMY) were down 0.5%.
The trial, known as PIVOT IO-001, tested bempeg in combination with Bristol Myers’ cancer immunotherapy drug Opdivo in patients with previously untreated unresectable or metastatic melanoma.
Patients in the control group were given Opdivo alone. Nektar and Bristol said that the addition of bempeg didn’t improve progression-free survival or the overall response rate.
“The bottom line is that Opdivo essentially performed in line with efficacy expectations from prior studies, and there was no added benefit from adding bempeg to Opdivo,” Nektar president and CEO Howard Robin said on an investor call.
In addition to the failed PIVOT IO-001 trial, Nektar and Bristol said that they would also end another trial of bempeg with Opdivo in patients at high risk of recurrence of melanoma.
“Today’s news is obviously very upsetting for all of us at Nektar,” Robin said on the call. “We were all highly surprised and disappointed when we received the news of the independent data monitoring community analysis.”
The trial had been a highly-anticipated readout for Nektar, and bempeg a key drug for the company. In 2018, Bristol Myers paid an eye-catching $1.9 billion up front to join with Nektar on bempeg, based on early data from what was at the time a continuing early-stage trial.
In a statement Monday, Bristol Myers’ senior vice president and head of oncology development, Jonathan Cheng, said that the company was disappointed with the results. “We are disappointed with the results of this trial, which we had hoped would lead to a new therapeutic option to treat metastatic melanoma,” Cheng said.
Robin said that the study raised no new safety concerns.
Nektar is currently testing bempeg in combination with Opdivo in a number of other indications, including genitourinary cancer. “Given the failure of PIVOT-IO-001, the probability of success of those trials are likely to be heavily discounted,” Mizuho analyst Mara Goldstein wrote.
On the investor call, Robin said that Bristol and Nektar were already preparing for a potential commercial launch of the drug. “This is one of the reasons why we’re truly surprised at the results announced today, which were unexpected by all of us,” Robin said.
“We’re all shocked and devastated by these results,” Robin said. Still, Robin said that he did not believe that the results had implications for the rest of Nektar’s pipeline, which includes a number of other experimental drugs.
Nektar shares had already been down 21.3% so far this year as of the end of trading on Friday. In a note out March 1, SVB Leerink analyst Daina Graybosch had called the coming months “extremely important” for Nektar, given the various expected bempeg trial readouts.
Shares of another biotech, Alkermes (ALKS), were also down 3.6% early Monday. In a separate note, Mizuho analyst Vamil Divan wrote that the failure of the bempeg trial could undermine confidence in an experimental Alkermes cancer drug called nemvaleukin, which works similarly to bempeg.
March 16, 2022
