Brief

Halozyme unveils mid-stage data for pancreatic cancer drug

Dive Brief:

  • Oncology drugmaker Halozyme Therapeutics on Thursday touted data showing its pancreatic cancer drug helped ward off the progression of disease for almost twice as long as other treatments, though only for a specific patient population.
  • In a Phase 2 trial dubbed HALO 202, the company enrolled 279 stage IV pancreatic cancer patients to test whether its drug PEGPH20 — in combination with two other anti-cancer treatments: Celgene's Abraxane (paclitaxel protein-bound) and gemcitabine — would improve progression-free-survival rates and reduce thromboembolisms.
  • Trial results showed patients with high levels of hyaluronan, a chemical that promotes cell growth and is thought to contribute to tumor development, who received PEGPH20 lived 9.2 months without their cancer progressing versus 5.2 months for those only receiving just Abraxane and gemcitabine. The disparity was much smaller in patients with low hyaluronan levels, however.

Dive Insight:

Halozyme's drug had no significant improvement on that group, according to a presentation the company released on Jan. 5. Progression-free-survival for patients with low hyaluronan levels who received the three-drug combination was 5.6 months compared to 5.3 months for those taking the two-drug combination.

Notably, the hazard ratio was .51 for those with high hyaluronan levels, but .88 for those with low levels.

Halozyme focused largely on the high hyaluronan population in its presentation, an action that resulted in some backlash from industry followers who criticized the company for not giving the fullest picture of the trial's outcomes.

"These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer," Halozyme's CEO Helen Torley said in a Jan. 5 statement. "We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide."

PEGPH20 is the company's lead candidate. The drug is a different version of its patented enzyme recombinant human hyaluronidase (rHuPH20) and works to break down hyaluronan. Halozyme made almost $10 million in the third quarter selling the bulk enzyme to Roche and others, and has licensed it out to AbbVie, Eli Lilly, Janssen and Pfizer. 

Halozyme has just one marketed product, Hylenex (hyaluronidase), an injectable that helps other medicines spread through the body and get absorbed. The product garnered $3.7 million in sales during the third quarter.

The company's announcement of positive trial data for its potential new drug sparked optimism among investors on Thursday, pushing shares up nearly 20% in pre-market trading. Shares were still up 12% in morning trading to linger near $12 per share. 

The American Cancer Society estimates more than 53,000 people in the U.S. were diagnosed with pancreatic cancer last year and nearly 42,000 died from it. The five-year survival rates for stage IV of the disease range from 1% to 16% depending on whether the patient has the exocrine or neuroendocrine types. 

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Filed Under: Clinical Trials
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