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Gilead's (GILD) Trodelvy Combo Shows Promise in NSCLC Study

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Gilead Sciences, Inc. (GILD - Free Report) announced encouraging data from the mid-stage study evaluating its breast cancer drug Trodelvy for the treatment of metastatic non-small cell lung cancer (NSCLC).

NSCLC is one of the most common types of lung cancer and currently accounts for up to 85% of diagnoses.

The phase II EVOKE-02 study is an open-label, global, multi-center, multi-cohort study evaluating Trodelvy in combination with Merck’s (MRK - Free Report) Keytruda with or without chemotherapy, regardless of PD-L1 expression, in patients with advanced or metastatic NSCLC without actionable genomic alterations.

As per the status of the cancer or PD-L1 expression, patients were assigned to cohorts. Patients were assigned to Cohorts A or B according to tumor proportion score (TPS) status. While Cohort A enrolled patients with squamous/non-squamous NSCLC with a TPS ≥ 50%, Cohort B enrolled patients with squamous/non-squamous NSCLC with a TPS < 50%. Patients enrolled in Cohorts A or B received the combination of Trodelvy and Keytruda.

Patients enrolled in Cohorts A or B received the combination of Trodelvy and Keytruda.

Results show encouraging activity of Trodelvy in combination with Keytruda in first-line metastatic NSCLC across all PD-L1 subgroups and histologies studied.

Data showed a confirmed and unconfirmed objective response rate (ORR) of 69% and a disease control rate (DCR) of 86% in Cohort A (n=29). Confirmed and unconfirmed ORR was 44% and DCR was 78% in Cohort B (n=32). Across both cohorts, ORR was 56% and DCR was 82%. The median duration of response (DoR) was not reached at the time of data cut-off and the DoR rate at six months was 88% in both cohorts.

The results support further investigation of the combination in the first-line metastatic NSCLC.

The company is also evaluating the phase III EVOKE-03 study of Trodelvy in combination with Keytruda versus Keytruda monotherapy for patients with first-line PD-L1-high metastatic NSCLC.

Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy is also approved in the United States and the European Union to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy has also obtained accelerated approval for treating certain patients with second-line metastatic urothelial cancer (UC) in the United States.

Apart from NSCLC, the drug is also being evaluated in other TNBC, HR+/HER2- and metastatic UC populations, as well as in a range of tumors where Trop-2 is highly expressed, including metastatic small cell lung cancer, head and neck cancer and endometrial cancer.

We remind investors that Gilead entered into two clinical trial collaboration and supply agreements with Merck in January 2022 to evaluate the combination of Trodelvy and Keytruda in the EVOKE-02 signal-seeking study and the ongoing EVOKE-03 study in first-line NSCLC.

Shares of Gilead have lost 11.5% in the year so far compared with the industry’s decline of 13.4%.

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The uptake of the breast cancer drug Trodelvy has also been strong and its approval in additional geographies will further boost sales and advance Gilead’s efforts to diversify in the lucrative oncology space as its leading HIV business faces competition.

The drug’s sales came in at $482 million in the first half of 2023.

The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in relapsed or refractory (R/R) large B-Cell lymphoma and Tecartus in R/R acute lymphoblastic leukemia and mantle cell lymphoma.

Merck’s Keytruda is approved for various oncology indications.

Zacks Rank and Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Exelixis (EXEL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while the earnings estimate for 2024 is currently pegged at 2 cents per share.

Shares of EXEL have gained 37.8% year to date. Earnings estimates for 2023 have risen by 9 cents to 98 cents.


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