Phase 2 results showed an objective response rate of 62.5%.

  • The trial evaluated 24 patients who received a single infusion of Lifileucel with Merck’s Keytruda.
  • The trial showed a complete response rate of 29.2%.
  • The company expects its cash position to fund operations into the second half of 2028.

Iovance Biotherapeutics (IOVA) was in the spotlight on Friday after the biotech firm reported promising results from a Phase 2 trial of its experimental cell therapy Lifileucel, combined with Merck’s (MRK) Keytruda, in patients with advanced melanoma.

IOVA shares were down 1.1% at the time of writing, tracking the broader selloff in biotech stocks. The State Street SPDR S&P Biotech ETF (XBI) was also down 1.1%.

Median Overall Survival Not Reached After More Than Four Years Of Follow-Up

The company said its Phase 2 IOV-COM-202 trial evaluated 24 patients who received a single infusion of Lifileucel with Keytruda. The results showed an objective response rate (ORR) of 62.5%, meaning nearly two-thirds of patients experienced significant tumor shrinkage or disappearance.

The trial also showed a complete response (CR) rate of 29.2%, indicating nearly a third of the patients had no detectable signs of cancer following treatment.

Crucially, the median overall survival had not been reached after a median follow-up of 50.9 months. Lifileucel already received accelerated U.S. Food and Drug Administration (FDA) approval in February 2024.

“The final Cohort 1A results demonstrate unprecedented efficacy and a potentially best-in-class clinical profile for Lifileucel combined with Pembrolizumab in frontline advanced melanoma,” said Noah Berkowitz, Chief Medical Officer at Iovance.

Iovance will present the first clinical data for Lifileucel in soft tissue sarcomas on October 26.

IOVA’s Pipeline In Focus

Iovance’s pipeline also includes studies in lung, endometrial and soft tissue cancers. The FDA recently granted Fast Track designation for Lifileucel in certain soft tissue sarcomas.

The company had about $304 million in cash, investments and restricted cash as of June 30, 2026, which it expects will fund its operations into the second half of 2028.

Retail Says IOVA To Be Acquired By End Of 2027

Retail sentiment surrounding IOVA on Stocktwits improved to ‘neutral’ from ‘bearish’ over the past 24 hours.

One user speculated the drug’s total addressable market was $36 billion.

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Another user speculated that Iovance would be acquired by the end of next year.

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IOVA shares have seen strong buying interest so far this year, surging nearly 460%.

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