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ALX Oncology (ALXO) Up 56% on Upbeat Gastric Cancer Study Data

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ALX Oncology Holdings (ALXO - Free Report) announced positive interim data from the phase II portion of its phase II/III ASPEN-06 study evaluating its lead candidate evorpacept as part of a four-drug combination therapy in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.

The phase II portion of the study randomized patients into either of the two arms – the evorpacept-combination treatment arm and the control group arm. Data from the study showed that patients in the evorpacept-combination treatment arm confirmed an overall response rate (“ORR”) of 52%, compared to the 22% ORR achieved in the control group arm.

Patients in the evorpacept-combination treatment arm received a combination of evorpacept, trastuzumab, Eli Lilly’s (LLY - Free Report) Cyramza (ramucirumab) and paclitaxel. On the other hand, patients in the control arm received a combination of trastuzumab, Cyramza and paclitaxel. The study enrolled patients with second and third-line gastric/GEJ cancer.

Shares of ALX Oncology were up 56.1% on Tuesday following the announcement of these results. The study is yet to reach the median duration of response (“mDOR”) in the evorpacept-combination treatment arm compared to 7.4 months in the control group arm. Treatment with evorpacept was also well tolerated and the drug’s safety profile was consistent with previously conducted clinical studies.

The 52% ORR achieved in the evorpacept-combination treatment arm was also superior to the 28% ORR achieved in the phase III RAINBOW study (conducted by Eli Lilly), which evaluated the combination of Cyramza and paclitaxel. Per management, Cyramza-paclitaxel is the regulatory benchmark and the current global standard of care in second-line gastric/GEJ cancer.

Shares of ALX Oncology have lost 33.3% year to date compared with the industry’s 18.2% decline.

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ALX Oncology intends to report final data from the phase II portion of the ASPEN-06 study next year in the second quarter. Based on this data, management will start the phase III portion of the study before 2024-end. The phase III portion will evaluate the evorpacept-combination therapy against a combination of Lilly’s Cyramza and paclitaxel.

Lilly’s Cyramza is approved for use, with or without paclitaxel, to treat patients with advanced or metastatic gastric/GEJ cancer with disease progression on or after prior chemotherapy. Trastuzumab is approved with chemotherapy to treat HER2-positive gastric/GEJ cancers. A combination of trastuzumab, Cyramza and paclitaxel is yet to be approved by the FDA.

Evorpacept, a next-generation CD47 blocker, is being developed for treating multiple cancer indications. ALX Oncology is evaluating evorpacept with several leading anti-cancer agents across several early-to-mid-stage studies to treat multiple cancer indications, including head and neck squamous cell carcinoma, breast cancer, and other solid tumors.

If successfully developed and upon potential approval, evorpacept can tap into a market with significant potential and drive growth for ALX Oncology, as it will be able to generate revenues from evorpacept’s sales.

 

Zacks Rank & Stocks to Consider

ALX Oncology currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the overall healthcare sector include Annovis Bio (ANVS - Free Report) and Vaxxinity (VAXX - 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.

In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 33.8%.

Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.

In the past 60 days, estimates for Vaxxinity’s 2023 earnings per share narrowed from 69 cents to 58 cents. During the same period, the loss estimates per share for 2024 have improved from 70 cents to 54 cents. Year to date, shares of Vaxxinityhave lost 10.0%.

Earnings of Vaxxinity beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 10.94%. In the last reported quarter, Vaxxinity’s earnings beat estimates by 31.25%.

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