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AbbVie (ABBV) Posts Encouraging Data From Lung Cancer Study

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AbbVie (ABBV - Free Report) announced top-line data from the single-arm phase II LUMINOSITY study on its investigational antibody-drug conjugate (ADC) candidate, telisotuzumab-vedotin (Teliso-V), in previously treated non-small cell lung cancer (NSCLC) patients with c-Met overexpression.

Management split its analysis between patients with high and intermediate c-Met expression. Data from the study showed that study participants treated with Teliso V achieved an overall response rate (ORR) of 35% across c-Met high patients and 23% across c-Met intermediate patients.

These results were lower than the interim results shared by AbbVie last year in January, wherein response rates of 53.8% and 25% were reported across c-Met high and c-Met intermediate patients, respectively.

Despite lower results, treatment with Teliso-V achieved meaningful clinical outcomes in other endpoints of the LUMINOSITY study, including median duration of response (DoR) and median overall survival (OS). Treatment with Teliso-V achieved a median DoR of 9 months and 7.2 months and a median OS of 14.6 months and 14.2 months across c-Met high and c-Met intermediate patients, respectively. The safety profile of Teliso-V was consistent with previous findings and no new safety concerns were identified.

AbbVie plans to discuss the above results with the FDA and other regulatory authorities across the globe with the intent to seek accelerated approval for Teliso-V in c-Met overexpressing NSCLC.

Year to date, shares of AbbVie have declined 14.3% against the industry‘s 3.8% rise.

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Per management, c-Met overexpression is found in 25% of advanced EGFR wild-type NSCLC patients and is also associated with a poor prognosis for these patients. Currently, there are no approved therapies for patients with c-Met overexpressing NSCLC.

Teliso-V has been developed by AbbVie to target c-Met protein, which is overexpressed in many solid tumors, including NSCLC. Management is evaluating Teliso-V as a monotherapy in the late-stage TeliMET NSCLC-01 study in patients with previously treated c-Met overexpressing EGFR wild-type non-squamous NSCLC.

AbbVie is conducting an early-stage study evaluating Teliso-V in combination with several other approved drugs, including AstraZeneca’s (AZN - Free Report) EGFR inhibitor Tagrisso (osimertinib) across a range of c-Met-expressing solid tumors.

One of AstraZeneca’s blockbuster drugs, Tagrisso is approved by the FDA to treat certain types of EGFR+ non-small cell lung cancer (NSCLC) indications. In the first nine months of 2023, AstraZeneca recorded $4.4 billion from Tagrisso product sales.

 

Zacks Rank & Key Picks

AbbVie currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) and Puma Biotechnology (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 16.9% in the year-to-date period.

CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.

In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have increased from 67 cents to 73 cents. During the same period, the earnings estimates per share for 2024 have risen from 55 cents to 62 cents. Shares of PBYI have lost 8.3% in the year-to-date period.

Earnings of Puma Biotechnology beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average surprise of 76.55%. In the last reported quarter, Puma Biotechnology’s earnings beat estimates by 13.33%.

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