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Affimed (AFMD) Soars on Upbeat Follow-Up Data From NSCLC Study

Affimed N.V. AFMD surged 68.5% after the company reported follow-up efficacy data from the EGFR wild-type (EGFRwt) cohort and initial clinical efficacy data from the EGFR mutant (EGFRmut) cohort of the ongoing early to mid-stage study of AFM24 to treat non-small cell lung cancer (NSCLC) patients.

The phase I/IIa AFM24-102 study is evaluating AFM24 in combination with Roche’s RHHBY immuno-oncology drug, Tecentriq (atezolizumab), in heavily pre-treated NSCLC patients.

Please note that the company first reported encouraging initial data from the EGFRwt cohort of the NSCLC study in December last year. Affimed stated that 15 patients were response-evaluable as of the updated data cutoff on May 13, 2024, out of the 17 EGFRwt patients who are currently undergoing treatment in the AFM24-102 study.

Of these 15 patients, confirmed objective responses (ORs) were observed in four patients, one complete response (CR) and three partial responses (PR). Additionally, eight patients achieved stable disease (SD), signifying a disease control rate of 71%.

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The median progression-free survival was 5.9 months with a median follow-up of 7.4 months. It is important to note that three of the four patients who achieved confirmed ORs, experienced an ongoing duration of response of more than seven months.

All four patients who achieved confirmed ORs were resistant to checkpoint inhibitor treatment before the phase I/IIa AFM24-102 study. This indicates that the combination therapy of AFM24 and Roche’s Tecentriq has the potential to help overcome the resistance to existing therapies, thereby addressing an unmet medical need.

Year to date, shares of Affimed have gained 17.3% against the industry’s 6.6% decline.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

The initial data from the EGFRmut patient cohort comprised data readout from 13 heavily pretreated patients (out of 21 patients who are currently undergoing treatment) who were response-evaluable after treatment with AFM24 in combination with Roche’s Tecentriq.

The combination therapy demonstrated encouraging signals of clinical activity, including one CR, three PRs and six patients with SD and all responses were ongoing as of the data cut-off. Based on such data, management believes that the AFM24/Tecentriq combo has the potential to improve efficacy outcomes in EGFRmut NSCLC patients.

Affimed reported that the combo therapy was overall well-tolerated and demonstrated a manageable safety profile. Side effects of treatment were consistent with the known safety profiles of these agents and were mostly mild to moderate in severity.

The company expects to enroll up to 40 patients in the EGFRwt NSCLC cohort and up to 25 patients in the EGFRmut cohort of the phase I/IIa AFM24-102 study. Further updates from the study are anticipated in the second half of 2024.

AFM24 is simultaneously being evaluated as a monotherapy and in combination with adoptive NK cells in two separate early to mid-stage studies to treat multiple EGFR+ solid tumors.

Please note that Affimed’s clinical-stage pipeline comprises two other investigational candidates, AFM13 and AFM28, which are currently undergoing development either as a monotherapy or in combination with other agents for several oncology indications.

Roche’s Tecentriq is currently approved in the United States, EU and several other countries to treat some of the most aggressive and difficult-to-treat forms of cancer, including advanced lung cancer, urothelial cancer and breast cancer.

Affimed N.V. Price and Consensus

Affimed N.V. Price and Consensus
Affimed N.V. Price and Consensus

Affimed N.V. price-consensus-chart | Affimed N.V. Quote

Zacks Rank and Other Stocks to Consider

Affimed currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the drug/biotech industry are ALX Oncology Holdings ALXO and Annovis Bio ANVS, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have plunged 39.8%.

ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.

In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $2.93 to $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.83 to $1.95. Year to date, shares of ANVS have plunged 63.5%.

ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

Affimed N.V. (AFMD) : Free Stock Analysis Report

Annovis Bio, Inc. (ANVS) : Free Stock Analysis Report

ALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report

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Zacks Investment Research