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Gilead writes $2.4B off Trodelvy as CEO underscores 'time of focused execution'

2024-04-26

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临床3期并购细胞疗法

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech.

After a negative phase 3 readout, Gilead Sciences is Gilead a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition.

Gilead has cut the carrying value Gilead Sciences$3.5 billion in its first-quarter report, from Trodelvylion at the end of 2023, Chief Financial Officer Ansolid tumorson told investors during a call Thursday.

Gileadve comes after a January reportTrodelvyase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price.

The write-off reflects a “smaller addressable market that TrodelvyTROP2-directedmong second-line-plus metastatic non-small cell lung cancer patients, a delay in expected launch timinnon-small cell lung cancerve activity,” Dickinson said.Gilead

Gilead remains confident that Trodelvy will deliver attracTrodelvyurns over time, with a development pmetastatic non-small cell lung cancer lines of therapy, Dickinson added.

Gileadvy is the centerpiece ofTrodelvys $21 billion acquisition of Immunomedics in 2020. In the first quarter, the drug delivered a 39% sales increase to $309 million. While concerns that Gilead overpaid were raised from the beginning, Dickinson now said Gilead is exploring opportunities that were not included in the initial deal model.

Details of the failed EVOKE-01 Gileadwill be shared at the upcomingImmunomedicsciety of Clinical Oncology annual meeting. Despite the primary endpoint flop, the full dataset “motivates us Gileadforward in lung cancer, including discussions with regulatorsGileadef Medical Officer Merdad Parsey said during the call. The company will share more once the results are provided, he said.

Trodelvy has a busy year ahead. Besides the EVOKE-01 trial, Gilead has seven ongoing phase 3 trials across breast, bladder and lung cancers, and plans to start another phase 3 in endometrial cancer in 2024lung cancer

Readouts and updates are expected later this year from the mGileadohort phase 3 EVOKE-02 trial, including data from first-line NSCLC patients that got a combination of Trodelvy, Mendometrial cancerd chemotherapy. The confirmatory TROPiCS-04 trial for Trodelvy in bladder cancer could read out overall survival results this year, Parsey said. The phase 3 ASCENT-03 study in first-line PD-L1-negative triple-negative breast cancer will also have an update.

Gilead is shoring up Trodelvy’s clinical data as AstraZeneca and Daiichi Sankyo are closing in on an FDA approval for their rivNSCLCOP2 ADC, datopotamab deruxtecan (DatTrodelvyn MerckousKeytrudaed nonsquamous NSCLC. The FDA has set Dec. 20 as the targTrodelvyion bladder cancer PD-L1-negative triple-negative breast cancer PD-L1-negative

Gileadurry of Trodelvy developments accentuates wAstraZenecaCEO DDaiichi Sankyod “a time of focused eFDAution” at the big biotech.datopotamab deruxtecan (Dato-DXd)nonsquamous NSCLC FDA

Cell therapies, the other pillar of Gilead’s growing Gileadgy portfolio, have recently reached a bottleneck. Sales from the CD19 CAR-Ts, Yescarta and Tecartus, have been relatively flat sequentially for the last three quarters. The two therapies together brought in $480 million in sales in the first quarter, versus $486 million in the third quarter of 2023 and $466 million in the last three months of the year. The FDA has installed new boxed warnings on the two CAR-T therapies’ labels reflecting a class-wide concern of secondary T-cell malignancies following the treatment of existing CAR-Ts.

The lack of growth momentum was the Gilead of an infrastructure bottleneck at designated treatment centers. To solve the proCD19 CAR-Tsd Yescartang toTecartusthe number of authorized centers and affiliated satellites, while also driving increased referrals from community doctors, chief commercial officer, Johanna Mercier, said on the call. The company earlier this year established a flagship community collaborationFDAth Tennessee Oncology, she said.T-cell malignancies CAR-Ts

“We’ve identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, anGileadill continue to refine this blueprint so that we become more efficient at onboarding new centers over time,” Mercier said.Tennessee Oncology

Gilead expects to see the fruits of the expansion toward the end of 2024, she added.

Gileadead’s bread-and-butter HIV franchise, Biktarvy remains king in the market with sales reaching $2.9 billion and market share at 49% in the first quarter. But the company is racing against GSK on developing long-acting regimens.

GilGileadans to advance a long-delayed phase 3 trial later this year for long-acting Sunlenca (lenacapavir) with Merck’s islatravir as a once-weekly regimen, plus a phase 2 trial for a combinatGSK of a capsid inhibitor and a novel integrase inhibitor. Meanwhile, Gilead is looking to potentially launch lenacapavir as early as late 2025 as the first twice-yearly PrEP option for HIV.

Gileade of antiviral and oncology, Gilead just wrapped up the $4.3 billion acquisitioSunlencaaBlenacapavirtics anMercknedislatravir disease candidate seladelpar, which has filings before the FDA and thecapsid inhibitor capsidean Medicines Agency asintegrase inhibitorimary biliaryGileadngitis.lenacapavir

If the FDA clears the drug in AugusGileadead expects to leverage its liver disease expertiCymaBay Therapeutics hepatitis C virliver disease The companseladelparforce currently covers nearly 8FDAof the U.European Medicines Agency, Mercier said.primary biliary cholangitis