With Gilead Sciences' stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.
After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug's every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca's approved patient population represents just 2% of adults with HIV.
That approval was just “the beginning of the rest of this journey,” Gilead's vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O'Day said on Gilead's second-quarter earnings call.
In June, Sunlenca achieved an “unprecedented” phase 3 win as a PrEP med with 100% efficacy in a study of cisgender women. In the trial, no infections were reported among more than 2,000 women who took Sunlenca.
The next hurdle for the drug is an ongoing study in different populations including cisgender gay men, transgender women and men and nonbinary people. A big difference in the two study populations is varying levels of PrEP awareness and compliance, Gilead's chief commercial officer Johanna Mercier noted on the company's conference call.
PrEP for HIV is “not a typical market,” Mercier said. Patients essentially aren’t sick or unwell, making compliance on a daily oral pill all the more challenging.
“We have to think completely differently about what lenacapavir could offer all of these people and really make a dent in this HIV epidemic,” Mercier said.
The company is positioning the drug as the first long-acting PrEP option with a twice-yearly dosing schedule.
Already, Gilead has kept a hold in the PrEP market with its Truvada follow-on therapy Descovy, but Sunlenca offers a chance to “redefine the PrEP market as a whole,” Mercier said.
GSK was the first to launch a long-acting PrEP drug, but Gilead’s option so far takes the cake on time between doses. GSK’s Apretude can be administered up to every two months, and the British drugmaker is looking to keep up with four- and six-month options that are in development. GSK has said it expects to launch those options later this decade.
Meanwhile, during the second quarter, Gilead's HIV business made up the bulk of its revenue haul with $4.7 billion in quarterly sales.
On the treatment side, Gilead's leading HIV drug Biktarvy contributed $3.2 billion during the period. The medicine holds more than 49% of the U.S. HIV treatment market, a 3% increase from last year and the 24th consequence quarter of market-share gains.
Elsewhere, on the oncology front, Gilead is leaning on Trodelvy's status as a standard of care in second-line metastatic triple-negative breast cancer after the antibody-drug conjugate suffered clinical setbacks in non-small cell lung cancer and bladder cancer.
The drugmaker hopes to move the needle in earlier lines of triple-negative breast cancer therapy in an ongoing phase 3. If successful, the trial could support global filings. Gilead “continues to assess” the path ahead in the other cancer areas, O’Day said.
All told, Gilead’s total sales output in the second quarter increased 5% to $7 billion, with growth contribution across the company's offerings in HIV, liver disease and oncology.