Bill Grossman

Feb 3, 2023

Nicole DeFeudis Editor Fol­low­ing a promise last year to go “big and fast in breast can­cer,” Gilead has se­cured a win for Trodelvy in the most com­mon form. The drug was ap­proved to treat HR-pos­i­tive, HER2-neg­a­tive breast can­cer pa­tients who’ve al­ready re­ceived en­docrine-based ther­a­py and at least two oth­er sys­temic ther­a­pies for metasta­t­ic can­cer, Gilead an­nounced on Fri­day. Bill Gross­man Trodelvy won its first in­di­ca­tion in metasta­t­ic triple-neg­a­tive breast can­cer back in 2020, and has since added urothe­lial can­cer to the list. HR-pos­i­tive HER2-neg­a­tive breast can­cer ac­counts for rough­ly 70% of new breast can­cer cas­es world­wide per year, ac­cord­ing to se­nior VP of on­col­o­gy clin­i­cal de­vel­op­ment Bill Gross­man, and many pa­tients de­vel­op re­sis­tance to en­docrine-based ther­a­pies or wors­en on chemother­a­py. “As pa­tients progress on en­docrine ther­a­pies and they get in­to oth­er com­bi­na­tions like CDK4/6, [they are] re­al­ly left on­ly with chemother­a­py at this stage,” Gross­man said. “For the pa­tients from TROP­iCS-02, me­di­an sur­vival is on­ly ap­prox­i­mate­ly one year.” Gilead tout­ed a bet­ter-than-ex­pect­ed read­out from the TROP­iCS-02 study at last year’s ES­MO con­fer­ence, in which pa­tients with HR+/HER2- metasta­t­ic breast can­cer who re­ceived Trodelvy af­ter pri­or en­docrine ther­a­py, CDK4/6 in­hibitors and two to four lines of chemother­a­py sur­vived a me­di­an of 14.4 months, com­pared to just 11.2 months for those who re­ceived chemo. Trodelvy al­so post­ed a 34% re­duc­tion in the risk of dis­ease pro­gres­sion or death (p=0.0003), Gilead said Fri­day. Trodelvy sales were up 79% last year, to­tal­ing $680 mil­lion and “re­flect­ing con­tin­ued adop­tion in metasta­t­ic TNBC in the Unit­ed States and Eu­rope,” Gilead an­nounced yes­ter­day in its Q4 earn­ings re­port. On the Q3 call, ex­ecs said they had al­ready be­gun prepar­ing for a po­ten­tial launch in HR-pos­i­tive HER2-neg­a­tive breast can­cer. The drug earned just $380 mil­lion in 2021. While Trodelvy was slapped with a boxed warn­ing back in 2020 for se­vere neu­trope­nia and se­vere di­ar­rhea, Gross­man said last week that “those are side ef­fects that I think most physi­cians are very, very ac­cus­tomed to.” Neu­trope­nia oc­curs when pa­tients have too few of a type of white blood cell called neu­trophils. “Physi­cians are pret­ty well-versed in try­ing to rec­og­nize those side ef­fects ear­ly and quick in­ter­ven­tions,” he said. Last year, As­traZeneca and Dai­ichi Sankyo’s ADC ther­a­py En­her­tu be­came the first ther­a­py ap­proved for a new­ly de­fined sub­set of breast can­cer pa­tients called HER2-low. About 60% of HER2-neg­a­tive pa­tients fall in­to the HER2-low buck­et, mean­ing they have some HER2 pro­teins, but not enough to be clas­si­fied as HER2-pos­i­tive. Gilead al­so post­ed HER2-low and IHC0 da­ta from the TROP­iCS-02 tri­al at ES­MO, with pro­gres­sion-free sur­vival com­ing in at 6.4 months in the treat­ment arm for HER2-low pa­tients, and five months for IHC0 pa­tients, the com­pa­ny an­nounced at the time. “In a post-hoc analy­sis, da­ta demon­strat­ed Trodelvy’s ef­fi­ca­cy across HER2-low and IHC0 sta­tus in pre-treat­ed metasta­t­ic breast can­cer pa­tients in the TROP­iCS-02 tri­al,” Gilead said in a news re­lease on Fri­day. Gross­man called the drug a “cor­ner­stone, bedrock to our pipeline” at ES­MO, while promis­ing to move in­to ear­li­er lines of ther­a­py and across “a wide num­ber of dif­fer­ent tu­mor types.” He re­it­er­at­ed those plans in an in­ter­view ahead of the re­cent de­ci­sion. “We’re go­ing fast and fu­ri­ous” in adding new prod­ucts to the port­fo­lio, he said. “And Trodelvy is one of those.” AUTHOR Kyle LaHucik Associate Editor The CEO and chief scientific officer of Vyant Bio are out the door as the little-known but publicly-listed neurodegenerative biotech searches for an exit or, if all else fails, a wind-down. The soul-searching bookends a winding journey for the biotech, which rebranded and transitioned from diagnostics company Cancer Genetics in 2021 after a merger with StemoniX. That came after a failed merger attempt with NovellusDx (now Fore Biotherapeutics ) in 2018. In the last few years, units have been sold off and the stock price $VYNT has plummeted from the $30 range to penny stock territory. Keep reading Endpoints with a free subscription Unlock this story instantly and join 158,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP News Reporter After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant. In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’” Keep reading Endpoints with a free subscription Unlock this story instantly and join 158,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Amber Tong Senior Editor GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease. But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted. Keep reading Endpoints with a free subscription Unlock this story instantly and join 158,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Nicole DeFeudis Editor Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid. Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them. Keep reading Endpoints with a free subscription Unlock this story instantly and join 158,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP